Substantially Equivalent 510(k) Device Applications

Alphabetical Listing by Applicant Name

Information updated through December 31, 2008

BK980025   5D Information Management
                Suite 500, 10025 - 102A Avenue
                Edmonton, Alberta Canada T5J 2Z2
           Trade Name:Plasma Center Module - 1.0
           Cleared Date: 18-MAY-1999
           Cleared Under Fifth Dimension Information
                Systems

BK990022   5D Information Management
                Suite 500, 10025 - 102A Avenue
                Edmonton, Alberta Canada T5J 2Z2
           Trade Name:Donor Management System - 1.0.0
           Cleared Date: 10-SEP-1999
           Cleared Under Fifth Dimension Information
                Systems

BK000026   5D Information Management
                Suite 500, 10025 - 102A Avenue
                Edmonton, Alberta Canada T5J 2Z2
           Trade Name:P2K Plasma Center Module 2000 -
                      1.0
           Cleared Date: 22-JUN-2000
           Cleared Under Fifth Dimension Information
                Systems

BK020058   5D Information Management
                Suite 500, 10025 - 102A Avenue
                Edmonton, Alberta Canada T5J 2Z2
           Trade Name:LOGIC - 1.0
           Cleared Date: 03-FEB-2003
           Cleared Under Fifth Dimension Information
                Systems

BK040040   5D Information Management
                Suite 500, 10025 - 102A Avenue
                Edmonton, Alberta Canada T5J 2Z2
           Trade Name:LOGIC - 2.0
           Cleared Date: 06-OCT-2004
           Cleared Under Fifth Dimension Information
                Systems

BK050060   5D Information Management
                Suite 500, 10025 - 102A Avenue
                Edmonton, Alberta Canada T5J 2Z2
           Trade Name:E-Interview (eQue) - 1.0.0
           Cleared Date: 24-MAY-2006
           Cleared Under Fifth Dimension Information
                Systems

BK060051   5D Information Management
                Suite 500, 10025 - 102A Avenue
                Edmonton, Alberta Canada T5J 2Z2
           Trade Name:HaemoConnect (eLynx) - 1.0.0
           Cleared Date: 06-MAR-2008

BK070011   ABSORBER AB
                Drottninggatan 33
                Stockholm, Sweden SE-103 95
           Trade Name:XM-ONE Transplantation Cross Match
           Cleared Date: 29-JUL-2008

BK960027   ADAC HealthCare Information System
                5 Greenway Plaza
                Suite 1900
                Houston, TX 77046
           Trade Name:ADAC Blood Bank System
           Cleared Date: 12-AUG-1998

BK050005   ALBA Bioscience
                21 Ellen's Glen Road
                Liberton, Edinburgh
                EH17 7QT
                Scotland, UNITED KINGDOM, United
                Kingdom EH17 7QT
           Trade Name:Quant-Rho FITC Anti-D for Fetal
                      Cell Assay
           Cleared Date: 27-SEP-2005

BK070033   ALBA Bioscience
                21 Ellen's Glen Road
                Liberton, Edinburgh
                EH17 7QT
                Scotland, UNITED KINGDOM, United
                Kingdom EH17 7QT
           Trade Name:AlbaQ-Chek Simulated Whole Blood
                      Controls
           Cleared Date: 27-JUL-2007

BK080027   ALBA Bioscience
                21 Ellen's Glen Road
                Liberton, Edinburgh
                EH17 7QT
                Scotland, UNITED KINGDOM, United
                Kingdom EH17 7QT
           Trade Name:ALBAcheck - BGS Reagent Control
                      for Anti-D
           Cleared Date: 29-JUL-2008

BK870009   ARK-Bio-Medical Canada Corp.
                #671 Rustico Road
                Winsloe, Canada CIE 1Z2
           Trade Name:WesLabs Model 601
           Cleared Date: 15-NOV-1989
           Cleared Under Rush Enterprises, Inc.

BK950048   Abbott Laboratories
                100 Abbott Park Road
                Abbott Park, IL 60064-3500
           Trade Name:Abbott Apheresis Results Tracking
                      System/AARTS
           Cleared Date: 24-JUN-1998

BK950052   Abbott Laboratories
                100 Abbott Park Road
                Abbott Park, IL 60064-3500
           Trade Name:Abbott DMS II Data Management
                      System
           Cleared Date: 12-AUG-1998

BK970042   Abbott Laboratories
                100 Abbott Park Road
                Abbott Park, IL 60064-3500
           Trade Name:ABBOTT PRISM System
           Cleared Date: 14-JUN-1999

BK010036   Abbott Laboratories
                100 Abbott Park Road
                Abbott Park, IL 60064-3500
           Trade Name:ABBOTT PRISM Retest Server - 1.0
           Cleared Date: 17-JUL-2002

BK060028   Abbott Laboratories
                100 Abbott Park Road
                Abbott Park, IL 60064-3500
           Trade Name:Abbott PRISM Retest Server
           Cleared Date: 07-JUN-2006

BK080015   Abbott Laboratories
                100 Abbott Park Road
                Abbott Park, IL 60064-3500
           Trade Name:ABBOTT PRISM Director V2.0
           Cleared Date: 24-APR-2008

BK810599   Accugenics, Inc.

                Costa Mesa, CA 92626
           Trade Name:Dade Rh Control Reagent
           Cleared Date: 31-MAR-1981

BK820004   Accugenics, Inc.

                Costa Mesa, CA 92626
           Trade Name:Trans-Type Reagents
           Cleared Date: 29-OCT-1982

BK830001   Accugenics, Inc.

                Costa Mesa, CA 92626
           Trade Name:Polycation Potentiator System
           Cleared Date: 06-MAY-1983

BK860038   Accugenics, Inc.

                Costa Mesa, CA 92626
           Trade Name:Data-Fi Thrombin Reagent
           Cleared Date: 16-JAN-1987
 

BK890018   Ackrad Laboratories
                70 Jackson Dr.
                Cranford, NJ 07016
           Trade Name:Ackrad Blood Warming Assembly
           Cleared Date: 21-SEP-1990

BK960071   AcroMetrix Corporation
                6058 Egret Court
                Benicia, CA 94510
           Trade Name:ViroSure Multi-Marker
           Cleared Date: 11-FEB-1998

BK040060   AcroMetrix Corporation
                6058 Egret Court
                Benicia, CA 94510
           Trade Name:VeriSure Pro External Quality
                      Controls
           Cleared Date: 03-MAY-2005

BK050061   AcroMetrix Corporation
                6058 Egret Court
                Benicia, CA 94510
           Trade Name:VeriSure Pro WNV RNA Negative
                      External Quality Control
                      VeriSure Pro WNV RNA Positive
                      External Quality Control
                      VeriSure Pro West Nile Virus (WNV)
                      RNA External Quality Controls:
           Cleared Date: 21-DEC-2005

BK060064   AcroMetrix Corporation
                6058 Egret Court
                Benicia, CA 94510
           Trade Name:VeriSure Pro HBV DNA External
                      Quality Control
           Cleared Date: 08-FEB-2007

BK960002   Activated Cell Therapy Inc.
                291 North Bernardo Avenue
                Mountain View, CA 94043
           Trade Name:ACT Buoyant Density Solution
           Cleared Date: 12-AUG-1996

BK940054   Alpha Scientific Corporation
                P.O. Box 725
                Southeastern, PA 19399
           Trade Name:SEG-Safe (TM)
           Cleared Date: 15-MAR-1995

BK950014   Alpha Scientific Corporation
                P.O. Box 725
                Southeastern, PA 19399
           Trade Name:SEG-SAFE
           Cleared Date: 31-MAR-1995

BK860014   Alpha Therapeutic Corporation
                5555 Valley Boulevard
                Los Angeles, CA 90032
           Trade Name:JMS Double Blood Collection Pack
           Cleared Date: 04-JUN-1986

BK870004   Alpha Therapeutic Corporation
                5555 Valley Boulevard
                Los Angeles, CA 90032
           Trade Name:Plasma Transfer Pack
           Cleared Date: 11-MAR-1987

BK950044   Alpha Therapeutic Corporation
                13111 Temple Avenue
                City of Industry, CA 91746
           Trade Name:Transfer Device
           Cleared Date: 18-OCT-1995

BK950021   Alton Dean Medical, Inc.
                1547 West 2290 South
                Woods Cross, UT 84087
           Trade Name:Alton Dean Model FW-437
           Cleared Date: 15-MAY-1995

BK960030   American Blood Resources Association
                PO Box 669
                Annapolis, MD 21404
           Trade Name:National Donor Deferral Registry
           Cleared Date: 20-MAR-1997

BK010012   American Blood Resources Association
                147 Old Solomons Island Rd.
                Annapolis, MD 21401
           Trade Name:National Donor Deferral Registry
                      (NDDR) - 1.0
           Cleared Date: 06-SEP-2001

BK960040   American Red Cross
                National Headquarters
                Washington, DC 20006
           Trade Name:NBCS 1.1
           Cleared Date: 28-FEB-1997

BK820016   American Red Cross Blood Services
                15601 Crabbs Branch Way
                Rockville, MD 20855
           Trade Name:ARC HLA Extended Trays
                      ARC HLA Trays
           Cleared Date: 01-JUN-1983

BK840015   American Red Cross Blood Services
                15601 Crabbs Branch Way
                Rockville, MD 20855
           Trade Name:Bovine Albumin 3%
           Cleared Date: 25-OCT-1984

BK880021   American Red Cross Blood Services
                15601 Crabbs Branch Way
                Rockville, MD 20855
           Trade Name:Frozen-Dried Bromelein
           Cleared Date: 21-DEC-1988

BK020032   American Red Cross Blood Services
                Quality and Regulatory Affairs
                1616 Fort Myer Drive
                Arlington, VA 22209
           Trade Name:NGTL Automation System (NAS) -
                      5.2.0
           Cleared Date: 20-MAR-2003

BK850010   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Rh-Hr Control
           Cleared Date: 27-DEC-1985

BK850023   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Amtec CM-Tec Control
           Cleared Date: 30-DEC-1985

BK860002   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Bovine Albumin 22%
           Cleared Date: 03-MAR-1986

BK860003   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Bovine Albumin 30%
           Cleared Date: 03-MAR-1986

BK860008   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Amtec Anti-A1 Lectin
           Cleared Date: 16-JUN-1986

BK860009   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Amtec Anti-N Lectin
           Cleared Date: 18-SEP-1987

BK860010   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Amtec PS
           Cleared Date: 16-DEC-1986

BK860020   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Amtec R-E-S System
           Cleared Date: 25-FEB-1987

BK860021   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Amtec Coombs Control Cells
           Cleared Date: 26-AUG-1986

BK860026   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Amtec Anti-H Lectin
           Cleared Date: 27-JAN-1987

BK860036   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Model Series, Mini & BB
           Cleared Date: 24-FEB-1987

BK870020   Amtec Diagnostics International Inc.
                1107 IH-45 South
                Conroe, TX 77305
           Trade Name:Amtec Ficin System
           Cleared Date: 02-FEB-1988

BK010024   Applied Biosystems
                850 Lincoln Centre Drive
                Foster City, CA 94404
           Trade Name:ViroSeq HIV-1 Genotyping System
           Cleared Date: 10-DEC-2002

BK030005   Applied Biosystems
                1401 Harbor Bay Parkway
                Alameda, CA 94502
           Trade Name:ViroSeq HIV-1 Genotyping System
           Cleared Date: 29-JAN-2003

BK010031   Applied Science, Inc.
                964-B Golden Gate Terrace
                Grass Valley, CA 95945
           Trade Name:Hemoflow Model 400 with Data
                      Scanner
           Cleared Date: 23-JAN-2002

BK990011   Applied Sciences, Inc.
                964-B Golden Gate Terrace
                Grass Valley, CA 95945
           Trade Name:HemoFlow Donor Monitor
           Cleared Date: 16-JUL-1999

BK990019   Applied Sciences, Inc.
                964-B Golden Gate Terrace
                Grass Valley, CA 95945
           Trade Name:HemoFlow Donor Monitor and Mixer
           Cleared Date: 05-OCT-1999

BK020031   Arlington Scientific, Inc.
                1840 North Technology Dr.
                Springville, UT 84663
           Trade Name:ASI TPHA Test
           Cleared Date: 30-JAN-2003

BK940022   Arrow International, Inc.
                P.O.Box 12888 3000 Bernville Road
                Reading, PA 19612
           Trade Name:Arrow Qwik-1 TM Blood and Fluid
                      Administration Set
           Cleared Date: 14-JUL-1994

BK070069   Arthrex, Inc.
                1370 Creekside Boulevard
                Naples, FL 34108
           Trade Name:Arthrex Double Syringe (ACP,
                      Autologous Conditioned Plasma)
                      System
           Cleared Date: 12-DEC-2008

BK910017   Assoc. of Cape Cod
                P.O. Box 224
                Woods Hole, MA 02543
           Trade Name:Control Standard
                      Endotoxin/Pepyrogeneration Valid.
           Cleared Date: 21-OCT-1991

BK940032   Augustine Medical, Inc.
                10393 West 70 th Street
                Eden Prairie, MN 55344
           Trade Name:Bair Hugger Patient Warming Device
           Cleared Date: 29-SEP-1994

BK930027   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:Accurun 1
           Cleared Date: 25-OCT-1994
           Cleared Under Boston Biomedica, Inc.

BK970004   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:ACCURUN155
           Cleared Date: 23-APR-1999
           Cleared Under Boston Biomedica, Inc.

BK990032   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:Accurun 106 HIV-1 Antigen
           Cleared Date: 20-JAN-2000
           Cleared Under Boston Biomedica, Inc.

BK010038   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:Accurun 1 Multimarker Negative
                      Control
           Cleared Date: 18-DEC-2001
           Cleared Under Boston Biomedica, Inc.

BK040006   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:ACCURUN 315 HIV-1 RNA Positive
                      Control
           Cleared Date: 12-OCT-2004
           Cleared Under Boston Biomedica, Inc.

BK040016   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:ACCURUN 305 HCV RNA Positive
                      Quality Control
           Cleared Date: 17-DEC-2004
           Cleared Under Boston Biomedica, Inc.

BK040064   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:ACCURUN 345 HIV-1 RNA, HCV RNA,
                      HBV DNA Positive Quality Control
                      Series 150
           Cleared Date: 29-OCT-2004
           Cleared Under Boston Biomedica, Inc.

BK040067   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:ACCURUN 803 Nucleic Acid Negative
                      Quality Control (HIV, HCV, HBV)
           Cleared Date: 19-NOV-2004
           Cleared Under Boston Biomedica, Inc.

BK060022   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:ACCURUN 365 West Nile Virus RNA
                      Positive Quality Control
           Cleared Date: 12-JUN-2006

BK060030   BBI Diagnostics, A SeraCare Company
                375 West Street
                West Bridgewater, MA 02379
           Trade Name:ACCURUN 804 Nucleic Acid Negative
                      Quality Control (HIV, HCV, HBV,
                      WNV)
           Cleared Date: 18-AUG-2006

BK030027   BD Biosciences
                2350 Qume Drive
                San Jose, CA 95131-1807
           Trade Name:BD IMAGN Microvolume Fluorimeter
                      and BD IMAGN rWBC Assay Kit
           Cleared Date: 10-JUL-2003

BK050062   BD Biosciences
                2350 Qume Drive
                San Jose, CA 95131-1807
           Trade Name:BD HLA-B27 kit
           Cleared Date: 27-OCT-2005

BK050073   BD Biosciences
                2350 Qume Drive
                San Jose, CA 95131-1807
           Trade Name:BD  HLA-B27 System
           Cleared Date: 16-FEB-2006

BK980011   BECTON DICKINSON  VACUTAINER  Systems
                1 Becton Drive
                Franklin Lakes, NJ 07417
           Trade Name:VACUTAINER Brand PLUS (Plastic)
                      Blood Collection Tube with EDTA
                      Anticoagulant
           Cleared Date: 07-JUN-1999

BK820008   BMT Incorporated
                7315 Hazeltine Boulevard
                Excelsior, MN 55331
           Trade Name:BMT Model 24 Bloodmixer
           Cleared Date: 22-OCT-1982

BK940031   Bard Radiology
                10115 Highway 142
                Covington, GA 30209
           Trade Name:True-Pulse Infusion Catheter
           Cleared Date: 27-APR-1995

BK900010   Baxter Healthcare Corporation
                1851 Delaware Parkway
                Miami, FL 33152
           Trade Name:Dade Chemically Modified Control
                      Reagent
           Cleared Date: 21-SEP-1990

BK920025   Baxter Healthcare Corporation
                1 Baxter Pkwy.
                Deerfield, IL 60015
           Trade Name:Dade Fetal-Cyte Screening Kit
           Cleared Date: 05-AUG-1993

BK940062   Baxter Healthcare Corporation
                1 Baxter Pkwy.
                Deerfield, IL 60015
           Trade Name:Cryocyte TM
           Cleared Date: 27-DEC-1994
 

BK950049   Baxter Healthcare Corporation
                9 Parker
                Irvine, CA 92618
           Trade Name:Cryocyte Freezing Container
           Cleared Date: 14-FEB-1996

BK960010   Baxter Healthcare Corporation
                9 Parker
                Irvine, CA 92618
           Trade Name:Cell Wash Set
           Cleared Date: 22-MAY-1996

BK020002   Baxter Healthcare Corporation
                550 North Brand Blvd.
                Glendale, CA 91203
           Trade Name:Serology SQL LIMS - 1.0
           Cleared Date: 07-AUG-2002

BK020059   Baxter Healthcare Corporation
                25212 West ILL Route 120
                RoundLake, IL 60073
           Trade Name:ALYX Component Collection System
           Cleared Date: 23-JAN-2003

BK030052   Bayer HealthCare Diagnostics Division
                700 BAY Street, Suite 1000
                Toronto, Ontario  M5G 1Z6 Canada
           Trade Name:TRUGENE HIV-1 Genotyping Kit and
                      OpenGene DNA Sequencing System
           Cleared Date: 08-OCT-2003

BK040052   Bayer HealthCare Diagnostics Division
                700 BAY Street, Suite 1000
                Toronto, Ontario  M5G 1Z6 Canada
           Trade Name:TRUGENE HIV-1 Genotyping Kit and
                      OpenGene DNA Sequencing System
           Cleared Date: 15-OCT-2004

BK050035   Bayer HealthCare Diagnostics Division
                P.O. Box 2466
                Berkeley, CA 94702-5828
           Trade Name:TRUGENE HIV-1 Genotyping Kit and
                      OpenGene DNA Sequencing System
           Cleared Date: 20-SEP-2005

BK010044   Beckman Coulter, Inc.
                11800 SW 147 Avenue
                (M/C: 31-B06)
                Miami, FL 33196-2500
           Trade Name:stemONE System for EPICS XL/ XL-
                      MCL Flow Cytometry Systems
           Cleared Date: 20-MAY-2002

BK020063   Beckman Coulter, Inc.
                11800 SW 147 Avenue
                (M/C: 31-B06)
                Miami, FL 33196-2500
           Trade Name:LeukoSure Enumeration Kit with
                      Leuko-Trol RBC Control Cells and
                      Leuko Trol Platelet Control Cells
           Cleared Date: 03-FEB-2003

BK040032   Beckman Coulter, Inc.
                11800 SW 147 Avenue
                (M/C: 31-B06)
                Miami, FL 33196-2500
           Trade Name:Stem-Kit Reagents
           Cleared Date: 05-MAY-2004

BK040055   Beckman Coulter, Inc.
                11800 SW 147 Avenue
                (M/C: 31-B06)
                Miami, FL 33196-2500
           Trade Name:stemCXP System for the FC 500 with
                      CXP Software
           Cleared Date: 16-SEP-2004

BK930010   Becton Dickinson Immunocytometry Systems
                2350 Qume Drive
                San Jose, CA 95131
           Trade Name:HLA-B27 Screening Systems
           Cleared Date: 09-SEP-1993

BK940015   Becton Dickinson Immunocytometry Systems
                2350 Qume Drive
                San Jose, CA 95131
           Trade Name:The HLA-B27 System
           Cleared Date: 24-OCT-1994

BK960087   Becton Dickinson Immunocytometry Systems
                2350 Qume Drive
                San Jose, CA 95131
           Trade Name:ProCount Progenitor Cell
                      Enumeration Kit
           Cleared Date: 04-JUN-1998

BK970038   Becton Dickinson Immunocytometry Systems
                2350 Qume Drive
                San Jose, CA 95131
           Trade Name:Procount Software
           Cleared Date: 04-FEB-1999

BK970046   Becton Dickinson Immunocytometry Systems
                2350 Qume Drive
                San Jose, CA 95131
           Trade Name:LeucoCOUNT Reagent
           Cleared Date: 14-AUG-1998

BK950068   Becton, Dickinson & Company
                1 Becton Drive, MC 300
                Franklin Lakes, NJ 07417-1885
           Trade Name:CMV Scan Card Test
           Cleared Date: 22-DEC-1995

BK040030   Becton, Dickinson & Company
                1 Becton Drive, MC 300
                Franklin Lakes, NJ 07417-1885
           Trade Name:BD Vacutainer Plus Plastic Serum
                      Tubes with Clot Activator
           Cleared Date: 05-MAY-2004

BK050036   Becton, Dickinson & Company
                1 Becton Drive, MC 300
                Franklin Lakes, NJ 07417-1885
           Trade Name:BD Vacutainer Plus K2EDTA Tubes
                      BD Vacutainer Plus Serum Tubes
                      BD Vacutainer SST Glass Tubes
                      BD Vacutainer SST II Advance Tubes
                      BD Vacutainer SST Plus Tubes
           Cleared Date: 24-FEB-2006

BK060046   Becton, Dickinson & Company
                1 Becton Drive, MC 300
                Franklin Lakes, NJ 07417-1885
           Trade Name:Bd.id Patient Identification
                      System for Transfusion Management
                      - V7.00
           Cleared Date: 13-FEB-2007

BK960001   Behring Diagnostics
                175 University  Avenue
                Westwood, MA 02090
           Trade Name:OPUS CMV
           Cleared Date: 09-OCT-1996

BK970035   BioAccess, Inc.
                8400 Cedar Street
                Silver Spring, MD 20910
           Trade Name:Bioaccess Marrow Collection System
           Cleared Date: 23-DEC-1998

BK000046   BioE, Inc.
                4280 Centerville Road
                St. Paul, MN 55127
           Trade Name:FluoroTrol Control Kits
           Cleared Date: 02-APR-2001
           Cleared Under BioErgonomics, Inc.

BK070067   BioE, Inc.
                4280 Centerville Road
                St. Paul, MN 55127
           Trade Name:PrepaCyte(R)-CB Processing System
           Cleared Date: 17-DEC-2008

BK050029   BioLife Plasma Services LP
                One Baxter Parkway
                Deerfield, IL 60015
           Trade Name:Donor Information System (DIS) -
                      3.1
           Cleared Date: 07-JUL-2005

BK060017   BioLife Plasma Services LP
                One Baxter Parkway
                Deerfield, IL 60015
           Trade Name:Donor Information System (DIS) -
                      3.2
           Cleared Date: 09-MAY-2006

BK080016   BioLife Plasma Services LP
                One Baxter Parkway
                Deerfield, IL 60015
           Trade Name:Donor Information System - v3.3
           Cleared Date: 02-JUL-2008

BK970017   BioMerieux
                1022 Hingham Street
                Rockland, MA 02370
           Trade Name:HLA-DR Oligo Detection Kit
           Cleared Date: 28-MAY-1998

BK860005   BioMerieux, Inc.
                5300 S. Portland Avenue
                Oklahoma City, OK 73119
           Trade Name:Plasma Collection Bag
           Cleared Date: 19-DEC-1986

BK870019   BioMerieux, Inc.
                5300 S. Portland Avenue
                Oklahoma City, OK 73119
           Trade Name:Quik-Chek
           Cleared Date: 19-MAY-1988

BK880003   BioMerieux, Inc.
                5300 S. Portland Avenue
                Oklahoma City, OK 73119
           Trade Name:Therapeutic Plasmapheresis
                      Collection Bag
           Cleared Date: 11-MAR-1988

BK920037   BioMerieux, Inc.
                5300 S. Portland Avenue
                Oklahoma City, OK 73119
           Trade Name:PEG+
           Cleared Date: 21-OCT-1993

BK960026   BioMerieux, Inc.
                100 Akzo Avenue
                Durham, NC 27712
           Trade Name:Status Symbol TM II System
                      Software
           Cleared Date: 16-MAR-1999
           Cleared Under Organon Teknika Corporation

BK000042   BioMerieux, Inc.
                100 Akzo Avenue
                Durham, NC 27712
           Trade Name:BacT/ALERT Culture Bottles
           Cleared Date: 15-FEB-2002

BK020022   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:BacT/ALERT SN Culture Bottle
           Cleared Date: 10-OCT-2002

BK020023   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:BacT/ALERT SA Culture Bottle
           Cleared Date: 10-OCT-2002

BK020060   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:NuclieSens HIV-1 QT RNA External
                      Controls
           Cleared Date: 18-DEC-2002

BK030034   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:BacT/ALERT BPN Culture Bottle
           Cleared Date: 18-JUL-2003

BK030035   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:BacT/ALERT BPA Culture Bottle
           Cleared Date: 06-AUG-2003

BK030075   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:BacT/ALERT BPN Culture Bottles
           Cleared Date: 08-MAR-2004

BK030076   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:BacT/ALERT BPA Culture Bottles
           Cleared Date: 08-MAR-2004

BK050037   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:BacT/ALERT BPA Culture Bottle
           Cleared Date: 27-DEC-2005

BK050043   BioMerieux, Inc.
                100 Rodolphe Street
                Durham, NC 27712
           Trade Name:BacT/ALERT BPN Culture Bottle
           Cleared Date: 27-DEC-2005

BK040036   Biomet Biologics, Inc.
                P.O. Box 587
                56 East Bell Drive
                Warsaw, IN 46581-0587
           Trade Name:GPS II Platelet Concentrate
                      Separation Kit
           Cleared Date: 18-JUN-2004
           Cleared Under Biomet,Inc.

BK050016   Biomet Biologics, Inc.
                P.O. Box 587
                56 East Bell Drive
                Warsaw, IN 46581-0587
           Trade Name:Fibrostik Plasma Concentrator
           Cleared Date: 20-JUL-2005
           Cleared Under Biomet,Inc.

BK070003   Biomet Biologics, Inc.
                P.O. Box 587
                56 East Bell Drive
                Warsaw, IN 46581-0587
           Trade Name:GPS II Platelet Concentration
                      Separation Kit with ACD-A
                      Plasmax Plasma Concentrator with
                      GPS Mini Platelet Concentrate
                      Separation Kit with ACD-A
           Cleared Date: 22-FEB-2007
           Cleared Under Biomet,Inc.

BK070026   Biomet Biologics, Inc.
                P.O. Box 587
                56 East Bell Drive
                Warsaw, IN 46581-0587
           Trade Name:GPS III Mini Platelet Concentrate
                      Separation Kit with ACD-A
                      GPS III Platelet Concentrate
                      Separation Kit with ACD-A
                      GPS III Platelet Concentrate
                      Separation Kit with ACD-A Double
                      Kit
           Cleared Date: 06-JUN-2007
           Cleared Under Biomet,Inc.

BK070036   Biomet Biologics, Inc.
                P.O. Box 587
                56 East Bell Drive
                Warsaw, IN 46581-0587
           Trade Name:Vortech Concentration System
           Cleared Date: 21-NOV-2007

BK080004   Biomet Biologics, Inc.
                P.O. Box 587
                56 East Bell Drive
                Warsaw, IN 46581-0587
           Trade Name:Clotalyst and GPS III Mini
                      Platelet Concentrate Separation
                      Kit with ACD-A
                      Clotalyst and GPS III Platelet
                      Concentrate Separation Kit with
                      ACD-A
           Cleared Date: 19-DEC-2008

BK970015   Biometric Imaging, Inc.
                1025 Terra Bella Avenue
                Mountain View, CA 94043
           Trade Name:CEQer RBC Assay
           Cleared Date: 18-SEP-1998

BK970016   Biometric Imaging, Inc.
                1025 Terra Bella Avenue
                Mountain View, CA 94043
           Trade Name:CEQer PRP Assay
           Cleared Date: 18-SEP-1998

BK970018   Biometric Imaging, Inc.
                1025 Terra Bella Avenue
                Mountain View, CA 94043
           Trade Name:STELLer CD34 Assay
           Cleared Date: 18-AUG-1998

BK980035   Biopool International, Inc.
                1230 Wilson Drive
                West Chester, PA 19380-4254
           Trade Name:SliDe Chek
           Cleared Date: 11-JUN-1999

BK840028   Biotech Research Laboratories, Inc.
                1600 East Gude Drive
                Rockville, MD 20850
           Trade Name:Run Control for HBsAg Assay
           Cleared Date: 25-JAN-1985

BK060066   Biotest AG
                Postfach 10 20 40
                D-63266 Dreiech, Germany
           Trade Name:TANGO Automated Blood Bank
                      Analyzer System, Version 3.0
                      Service Pack 4
           Cleared Date: 17-JAN-2007

BK950015   Biotest Diagnostics Corporation
                66 Ford Road, Suite 131
                Denville, NJ 07834
           Trade Name:Biotest DRB-SSO Typing Kit
           Cleared Date: 09-JUN-1995

BK960061   Biotest Diagnostics Corporation
                66 Ford Road, Suite 131
                Denville, NJ 07834
           Trade Name:Biotest DQB-ELPHA
           Cleared Date: 04-AUG-1997

BK960086   Biotest Diagnostics Corporation
                66 Ford Road, Suite 131
                Denville, NJ 07834
           Trade Name:Biotest High Resolution
                      Supplementary Kit
           Cleared Date: 03-JUL-1997

BK980007   Biotest Diagnostics Corporation
                66 Ford Road, Suite 131
                Denville, NJ 07834
           Trade Name:BIOTEST DRB-ELPHA Low Resolution
                      (Enzyme Linked Probe Hybridization
                      Assay)
           Cleared Date: 26-JAN-1999

BK980033   Biotest Diagnostics Corporation
                66 Ford Road, Suite 131
                Denville, NJ 07834
           Trade Name:LYMPHOSCREEN ABC 60
           Cleared Date: 15-DEC-1999

BK980044   Biotest Diagnostics Corporation
                66 Ford Road, Suite 131
                Denville, NJ 07834
           Trade Name:Lymphoscreen DR 30 x 2
           Cleared Date: 15-DEC-1999

BK020004   Biotest Diagnostics Corporation
                66 Ford Road, Suite 131
                Denville, NJ 07834
           Trade Name:Biotest HLA SSP Kit
           Cleared Date: 07-AUG-2002

BK080012   Biotest Medical Diagnostics GmbH
                P.O. Box 10 21 50
                63267 Dreiech, Germany
           Trade Name:(1) Seraclone Control ABO+Rh
                      (2) Coombscell-E
                      (3) MLB2
           Cleared Date: 23-JUL-2008

BK080013   Biotest Medical Diagnostics GmbH
                P.O. Box 10 21 50
                63267 Dreiech, Germany
           Trade Name:Alsevers Solution (510(k) exempt
                      but part of system)
                      Solidscreen II Control B
                      Solidscreen Negative Control
                      Tango Optimo  Automated Blood Bank
                      Analyzer System with version 3.1
           Cleared Date: 23-JUL-2008

BK820009   Biotest-Serum-Institut GmbH
                Flughafenstrasse 4
                6000 Frankfurt/Main 73, Germany
           Trade Name:Anti-HLA Leukocyte Typing Serum
           Cleared Date: 20-JAN-1983

BK820011   Biotest-Serum-Institut GmbH
                Flughafenstrasse 4
                6000 Frankfurt/Main 73, Germany
           Trade Name:Microdroplet Testing Tray
                      (Lymphotype ABC-72 Well)
           Cleared Date: 20-JAN-1983

BK830027   Biotest-Serum-Institut GmbH
                Flughafenstrasse 4
                6000 Frankfurt/Main 73, Germany
           Trade Name:Microtest Testing Tray (HLA-DR
                      Wells)
           Cleared Date: 26-APR-1984

BK890015   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:Blood Screening/Diagnostic Serum
                      Controls
           Cleared Date: 17-APR-1992

BK890019   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:Blood Bank Saline
           Cleared Date: 18-JUL-1990

BK920008   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:VIROTROL
           Cleared Date: 17-SEP-1992

BK920028   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:Virotrol HIV-2
           Cleared Date: 03-JUN-1993

BK930016   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:Virotrol I Reagents (CMV)
           Cleared Date: 16-NOV-1993

BK930033   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:Virotrol HIV-Ag
           Cleared Date: 27-SEP-1995

BK930034   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:Virotrol III
           Cleared Date: 27-JUL-1994
 

BK950011   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:Viroclear
           Cleared Date: 28-AUG-1995

BK960085   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:VIROTROL II
           Cleared Date: 03-OCT-1997

BK000041   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:Viroclear
           Cleared Date: 28-DEC-2000

BK060052   Blackhawk BioSystems,Inc.
                12945 Alcosta Blvd.
                San Ramon, CA 94583
           Trade Name:AmpliTrol III
           Cleared Date: 07-NOV-2006

BK960044   Blood Bank Computer Systems, Inc.
                1501 West Valley Highway, North
                Suite 101
                Auburn, WA 98001
           Trade Name:Blood Bank Control System
           Cleared Date: 15-OCT-1997

BK040056   Blood Bank Computer Systems, Inc.
                1002 15th St. SW, Suite 120
                Auburn, WA 98001-6502
           Trade Name:Blood Bank Control System (BBCS) -
                      5.0
           Cleared Date: 22-OCT-2004

BK040087   Blood Bank Computer Systems, Inc.
                1002 15th St. SW, Suite 120
                Auburn, WA 98001-6502
           Trade Name:BBCS Lab Interface Application
                      (BBCS Lab) - 5.0L
           Cleared Date: 15-FEB-2005

BK050013   Blood Bank Computer Systems, Inc.
                1002 15th St. SW, Suite 120
                Auburn, WA 98001-6502
           Trade Name:BBCS Mobile Application - 5.0M
           Cleared Date: 01-JUN-2005

BK940048   BloodCare
                9000 Harry Hines Blvd.
                Dallas, TX 75235
           Trade Name:LifeTrak /Lab (a.k.a. Lab*Care) -
                      V. 2.01
           Cleared Date: 01-OCT-1998

BK940025   Boston Scientific, Inc.
                1 Boston Scientific Place
                Natick, MA 01760-1537
           Trade Name:Katzen Thrombolysis Guideware
           Cleared Date: 24-JAN-1996

BK890009   C-six Diagnostics, Inc.
                9653 N. Granville Rd.
                Meguon, WI 53092
           Trade Name:Frozen Cell Panel Tray  (Human)
           Cleared Date: 02-AUG-1989

BK890010   C-six Diagnostics, Inc.
                9653 N. Granville Rd.
                Meguon, WI 53092
           Trade Name:Leukocyte Typing Serum Trays
                      (Human)
           Cleared Date: 02-AUG-1989

BK890011   C-six Diagnostics, Inc.
                9653 N. Granville Rd.
                Meguon, WI 53092
           Trade Name:Leukocyte Typing Serum Trays
                      (Human)
           Cleared Date: 02-AUG-1989

BK960049   CIS-US, Inc.
                10 de Angelo Drive
                Bedford, MA 01730
           Trade Name:DoseWriter
           Cleared Date: 25-MAR-1998

BK950024   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Platelet Filtration and
                      Storage Set
           Cleared Date: 29-NOV-1995
           Cleared Under COBE BCT

BK950056   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:Cobe Spectra LRD Leukoreduction
                      (System Versions)
           Cleared Date: 31-JAN-1996
           Cleared Under COBE BCT

BK950065   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:Cobe Spectrum Apheresis System
                      (stem cell collection)
           Cleared Date: 28-OCT-1998
           Cleared Under COBE BCT

BK960076   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra LRS Turbo System
           Cleared Date: 14-JUL-1997
           Cleared Under COBE BCT

BK970005   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:Focussed System
           Cleared Date: 13-OCT-1998
           Cleared Under COBE BCT

BK970023   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:Collection of pRBC Using the
                      Focussed System
           Cleared Date: 13-OCT-1998
           Cleared Under COBE BCT

BK980004   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra Apheresis System
                      Anticoagulant Free Flow
                      Restriction
           Cleared Date: 09-JUL-1998
           Cleared Under COBE BCT

BK990025   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:Cobe Trima
           Cleared Date: 07-APR-2000
           Cleared Under COBE BCT

BK990040   COBE Cardiovascular, Inc.
                1201 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Trima with the r/LS RBC
                      Leukoreduction Filter
           Cleared Date: 03-MAR-2000
           Cleared Under COBE BCT

BK050033   COBE Cardiovascular, Inc.
                14401 West 65th Way
                Arvada, CO 80004-3599
           Trade Name:COBE Angel Whole Blood Separation
                      System
           Cleared Date: 22-AUG-2005
           Cleared Under COBE BCT

BK060010   COBE Cardiovascular, Inc.
                14401 West 65th Way
                Arvada, CO 80004-3599
           Trade Name:COBE Angel Whole Blood Separation
                      System
           Cleared Date: 27-FEB-2006

BK040002   Care Fusion, Inc.
                1430 Spring Hill Road, Suite 510
                McLean, VA 22102
           Trade Name:wBlood Care - 1.0
           Cleared Date: 10-NOV-2004

BK080035   CaridianBCT
                10811 W. Collins Avenue
                Lakewood, CO 80215-4498
           Trade Name:COBE Spectra Apheresis System
                      Trima Accel Automated Blood
                      Component Collection System
           Cleared Date: 29-AUG-2008

BK080043   CaridianBCT
                10811 W. Collins Avenue
                Lakewood, CO 80215-4498
           Trade Name:Atreus Whole Blood Processing
                      System
           Cleared Date: 29-SEP-2008

BK080058   CaridianBCT
                10811 W. Collins Avenue
                Lakewood, CO 80215-4498
           Trade Name:Trima Accel Automated Blood
                      Component Collection System
           Cleared Date: 25-NOV-2008

BK990015   Carter BloodCare
                2205 Highway 121
                Bedford, TX 76021
           Trade Name:LifeTrak/Distribution - 2.03
           Cleared Date: 22-OCT-1999

BK990027   Carter BloodCare
                2205 Highway 121
                Bedford, TX 76021
           Trade Name:LifeTrak/Donor - 2.03
           Cleared Date: 15-DEC-1999

BK020051   Cascade Medical Enterprises, LLC
                20 Greenup Court
                Wayne, NJ 07470
           Trade Name:Cascade Medical Fibrinet,
                      Autologous Platelet System
           Cleared Date: 20-DEC-2002

BK060006   Cascade Medical Enterprises, LLC
                20 Greenup Court
                Wayne, NJ 07470
           Trade Name:Cascade Medical FIBRINET System
           Cleared Date: 16-FEB-2006

BK030033   Celera Diagnostics, LLC
                1401 Harbor Bay Parkway
                Alameda, CA 94502
           Trade Name:ViroSeq HIV-1 Genotyping System
           Cleared Date: 11-JUN-2003

BK030088   Celera Diagnostics, LLC
                1401 Harbor Bay Parkway
                Alameda, CA 94502
           Trade Name:ViroSeq HIV-1 Genotyping System
                      v2.0
           Cleared Date: 22-JAN-2004

BK060049   Celera Diagnostics, LLC
                1401 Harbor Bay Parkway
                Alameda, CA 94502
           Trade Name:ViroSeq HIV-1 Genotyping System
           Cleared Date: 31-AUG-2006

BK080026   Celera Diagnostics, LLC
                1401 Harbor Bay Parkway
                Alameda, CA 94502
           Trade Name:ViroSeq HIV-1 Genotyping System
                      v2.0
           Cleared Date: 10-JUL-2008

BK880002   Cellular Products
                688 Main Street
                Buffalo, NY 14202
           Trade Name:Blood Bank Refrigerator
           Cleared Date: 04-MAY-1988

BK950010   Centocor, Inc.
                200 Great Valley Parkway
                Malvern, PA 19355
           Trade Name:CAPTIA CMV-TA EIA
           Cleared Date: 22-MAR-1995

BK950051   Cerner Corporation
                2800 Rock Creek Parkway
                Kansas City, MO 64117-2551
           Trade Name:Pathnet Blood Center (L-2510)
           Cleared Date: 16-JUL-1997

BK950053   Cerner Corporation
                2800 Rock Creek Parkway
                Kansas City, MO 64117-2551
           Trade Name:Pathnet Blood Bank Transfusion (L-
                      2300)
           Cleared Date: 16-JUL-1997

BK950055   Cerner Corporation
                2800 Rock Creek Parkway
                Kansas City, MO 64117-2551
           Trade Name:Pathnet Blood Bank Donor (L2400)
           Cleared Date: 16-JUL-1997

BK960024   Cerner Corporation
                2800 Rock Creek Parkway
                Kansas City, MO 64117-2551
           Trade Name:PathNet Worksystem  Blood Bank
                      Transfusion (L2812)
           Cleared Date: 16-JUL-1997

BK990007   Cerner Corporation
                2800 Rock Creek Parkway
                Kansas City, MO 64117-2551
           Trade Name:HNA Millennium PathNet Blood Bank
                      Transfusion
           Cleared Date: 02-NOV-1999

BK030028   Cerner Corporation
                2800 Rock Creek Parkway
                Kansas City, MO 64117-2551
           Trade Name:Cerner Millennium PathNet Blood
                      Bank Donor (PA-22200) - 2003.01
           Cleared Date: 19-AUG-2003

BK060037   Cerner Corporation
                2800 Rock Creek Parkway
                Kansas City, MO 64117-2551
           Trade Name:Cerner Bridge Medical Transfusion
                      Administration and Specimen
                      Collections - 3.3
           Cleared Date: 24-MAY-2007

BK860025   Cetus Corporation
                1400 53rd Street
                Emeryville, CA 94608
           Trade Name:Pro Group System
           Cleared Date: 27-APR-1987

BK050021   Charter Medical, Ltd.
                3948-A Westpoint Blvd.
                Winston-Salem, NC 27103
           Trade Name:Charter Medical Transfer Set
           Cleared Date: 22-JUL-2005

BK060042   Charter Medical, Ltd.
                3948-A Westpoint Blvd.
                Winston-Salem, NC 27103
           Trade Name:Cell Freeze Liquid Nitrogen
                      Freezing Container
           Cleared Date: 03-OCT-2008

BK910003   CharterMed, Inc.
                3948-A West Point Blvd.
                Winston-Salem, NC 27103
           Trade Name:CharterMed Blood Freezing Bag
           Cleared Date: 11-MAR-1993

BK960043   CharterMed, Inc.
                3948-A West Point Blvd.
                Winston-Salem, NC 27103
           Trade Name:Charter Med Transfer Bags
           Cleared Date: 11-SEP-1996

BK000049   Chiron Corporation
                4560 Horton Street

                Emeryville, CA 94608-2916
           Trade Name:Chiron CPT Pooling Software,
                      Version 2.0.0.2
           Cleared Date: 04-DEC-2001

BK010025   Chiron Corporation
                4560 Horton Street
                Emeryville, CA 94608-2916
           Trade Name:Chiron Procleix NAT Tracker - 1.0E
           Cleared Date: 03-JAN-2002
           Cleared Under Rubin & Poor

BK030030   Chiron Corporation
                4560 Horton Street
                Emeryville, CA 94608-2916
           Trade Name:Procleix NAT Tracker
           Cleared Date: 23-MAY-2003
           Cleared Under Rubin & Poor

BK040058   Chiron Corporation
                4560 Horton Street
                Emeryville, CA 94608-2916
           Trade Name:Chiron CPT Pooling Software,
                      Version 2.0.0.2
           Cleared Date: 28-JUL-2004

BK040072   Chiron Corporation
                4560 Horton Street
                Emeryville, CA 94608-2916
           Trade Name:Procleix NAT Tracker Software
                      Version 2.1
           Cleared Date: 04-NOV-2004

BK050004   Chiron Corporation
                4560 Horton Street
                Emeryville, CA 94608-2916
           Trade Name:Procleix Optiva RAS
           Cleared Date: 08-APR-2005

BK060005   Chiron Corporation
                4560 Horton Street
                Emeryville, CA 94608-2916
           Trade Name:Chiron Procleix NAT Tracker - 3.0
           Cleared Date: 01-MAR-2006

BK070007   Chiron Corporation
                4560 Horton Street
                Emeryville, CA 94608-2916
           Trade Name:PROCLEIX NAT TRACKER
           Cleared Date: 06-MAR-2007
BK840008   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:IBM 2991 - Change of Ownership
           Cleared Date: 08-JUN-1984

BK840009   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:IBM 2997 - Change of Ownership
           Cleared Date: 08-JUN-1984

BK870022   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra Blood Component
                      Separator
           Cleared Date: 20-JUN-1988

BK900002   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra: Simultaneous
                      Collection of Platlets and Plasma
           Cleared Date: 21-JUN-1990

BK900003   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra: Change in
                      Anticoagulant Ratio
           Cleared Date: 14-NOV-1990

BK900004   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra:  Single Needle
                      System
           Cleared Date: 21-JUN-1990

BK910020   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE SPECTRATHERM
           Cleared Date: 02-NOV-1992

BK920011   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:Cobe Spectra with PCM
           Cleared Date: 15-MAY-1995

BK920036   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra Single-Needle
                      Extended Life Platelet (ELP) Set
           Cleared Date: 06-APR-1993

BK930017   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra Apheresis System
                      (Triple Platelet)
           Cleared Date: 27-JUL-1994

BK940016   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra Version 4
           Cleared Date: 20-SEP-1994

BK950030   Cobe Laboratories, Inc.
                1185 Oak Street
                Lakewood, CO 80215
           Trade Name:COBE Spectra Extended Life
                      Platelet Set
           Cleared Date: 15-FEB-1996

BK970007   Community Bio-Resources, Inc.
                2197 Parkway Lake Drive
                Hoover, AL 35244
           Trade Name:Donor Information System - 1.0
           Cleared Date: 09-APR-1997

BK960060   Community Blood Center of Greater Kansas
           City
                4040 Main Street
                Kansas City, MO 64111
           Trade Name:CBC Blood System, Version 1.2
           Cleared Date: 20-NOV-1997

BK920006   Connaught Laboratories Limited
                1755 Steeles Avenue West
                Willowdale, Canada
           Trade Name:CONTINENTAL REFRIG. BLD.BNK. MODEL
                      C-BBRA-1S
           Cleared Date: 17-JUL-1992

BK970010   Controlled Chemicals, Inc.
                317 S. Division
                Suite 9
                Ann Arbor, MI 48104
           Trade Name:CryoGuard Thermal Exposure
                      Indicator
           Cleared Date: 26-AUG-1997

BK940026   Cook, Inc.
                925 S. Curry Pike
                Bloomington, IN 47402
           Trade Name:Roubin Infusion Catheter
           Cleared Date: 29-JUN-1995

BK830008   Cooper Biomedical
                1230 Wilson Drive
                West Chester, PA 19380
           Trade Name:W.A.R.M.
           Cleared Date: 21-JUN-1983

BK850008   Cooper Biomedical
                1 Technology Court
                Malvern, PA 29355
           Trade Name:H.P.C.
           Cleared Date: 09-JAN-1986

BK850009   Cordis Laboratories, Inc.
                2140 North Miami Avenue
                Miami, FL 33127
           Trade Name:CORDIA HTLV-I
           Cleared Date: 03-OCT-1985

BK820007   Cry-O-Safe, Inc.
                999 Airport Road
                Lakewood, NJ 08701
           Trade Name:Plasma Safe
           Cleared Date: 26-JUL-1982

BK820018   Cryosan Inc.
                850 Providence Highway
                Dedham, MA 02026
           Trade Name:Dideco BT Series
           Cleared Date: 16-DEC-1982

BK820021   Cryosan Inc.
                850 Providence Highway
                Dedham, MA 02026
           Trade Name:Dideco  BT790/A
                      Dideco BT792
           Cleared Date: 03-JAN-1983

BK830015   Cryosan Inc.
                850 Providence Highway
                Dedham, MA 02026
           Trade Name:Dideco BT 125
                      Dideco BT 225
                      Dideco BT 375
                      Dideco BT 691
           Cleared Date: 31-OCT-1983

BK830016   Cryosan Inc.
                850 Providence Highway
                Dedham, MA 02026
           Trade Name:Dideco Progress BT 790/A
           Cleared Date: 07-FEB-1984

BK840011   Cryosan Inc.
                850 Providence Highway
                Dedham, MA 02026
           Trade Name:BT 765 Blood Cell Separator
                      Equipment
           Cleared Date: 10-APR-1985

BK840012   Cryosan Inc.
                850 Providence Highway
                Dedham, MA 02026
           Trade Name:BT 765 Elutriation Pump
           Cleared Date: 06-FEB-1985

BK850003   Cryosan Inc.
                850 Providence Highway
                Dedham, MA 02026
           Trade Name:Cryosan Pediatric Pack
           Cleared Date: 05-APR-1985

BK870003   Cryosan Inc.
                850 Providence Highway
                Dedham, MA 02026
           Trade Name:Cryo-PakTM System
           Cleared Date: 17-APR-1987

BK820014   Cutter Biological
                4th&Paker St,
                Berkley, CA 94701
           Trade Name:Plasma Pooling Bags
           Cleared Date: 08-FEB-1983

BK840010   Cutter Biological
                4th&Paker St,
                Berkley, CA 94701
           Trade Name:CLX Transfer Bag
           Cleared Date: 15-AUG-1984

BK860001   Cutter Biological
                4th&Paker St,
                Berkley, CA 94701
           Trade Name:Leukotrap System
           Cleared Date: 05-AUG-1986

BK860040   Cutter Biological
                4th&Paker St,
                Berkley, CA 94701
           Trade Name:Blood Collection Unit w/o
                      Anticoagulant
           Cleared Date: 24-JUN-1987

BK960012   CytoTherm LP
                110 Sewell Avenue
                Trenton, NJ 08610
           Trade Name:Cyto Therm (T-S)
           Cleared Date: 15-APR-1996
           Cleared Under Photo-Therm

BK980042   CytoTherm LP
                110 Sewell Avenue
                Trenton, NJ 08610
           Trade Name:CytoTherm J
           Cleared Date: 07-JAN-1999
           Cleared Under Photo-Therm
BK060027   CytoTherm LP
                110 Sewell Avenue
                Trenton, NJ 08610
           Trade Name:CytoTherm Plasma Thawing System
           Cleared Date: 01-AUG-2006

BK060063   CytoTherm LP
                110 Sewell Avenue
                Trenton, NJ 08610
           Trade Name:CytoTherm Cryoprecipitate Thawer,
                      Model CT-4T.6C
           Cleared Date: 04-MAY-2007

BK080019   CytoTherm LP
                110 Sewell Avenue
                Trenton, NJ 08610
           Trade Name:CytoTherm Plasma Thawing System
           Cleared Date: 16-JUL-2008

BK950060   Cytosol Laboratories, Inc.
                55 Messina Drive
                Braintree, MA 02184-6783
           Trade Name:Y-Type Rejuvenation Set PN7212
           Cleared Date: 25-NOV-1996

BK000022   DENCO, INC.
                P.O.BOX 9600
                Wilmington, DE 19809
           Trade Name:Total Containment Device
           Cleared Date: 18-APR-2000

BK990041   DENCO, INC.
                P.O.BOX 9600
                Wilmington, DE 19809
           Trade Name:Total Containment Device
           Cleared Date: 21-DEC-1999

BK950019   DUPACO
                2620 TEMPLE HEIGHTS DR.
                OCEANSIDE, CA 92056
           Trade Name:DUPACO BLOOD/FLUID WARMING SET
                      D25416
           Cleared Date: 27-APR-1995

BK950038   DUPACO
                2620 TEMPLE HEIGHTS DR.
                OCEANSIDE, CA 92056
           Trade Name:Dupaco Counterflo 300 Blood/Fluid
                      Warmer
           Cleared Date: 01-SEP-1995

BK020057   Data Innovations Inc.
                120 Kimball Ave., Suite 100
                South Burlington, VT 05430
           Trade Name:imExpress - 7.2.5
           Cleared Date: 29-JUL-2003
           Cleared Under Data Innovations
BK060053   Data Innovations Inc.
                120 Kimball Ave., Suite 100
                South Burlington, VT 05430
           Trade Name:Instrument Manager - 8.05.01.10
           Cleared Date: 05-JAN-2007

BK080052   Data Innovations Inc.
                120 Kimball Ave., Suite 100
                South Burlington, VT 05430
           Trade Name:INSTRUMENT MANAGER - V 8.07
           Cleared Date: 28-OCT-2008

BK960004   Defense Blood Standard System
                5205 Leesburg Pike
                Suite 1000
                Falls Church, VA 22041
           Trade Name:Defense Blood Standard System
                      (DBSS) (Version 1.0/1.03)
           Cleared Date: 01-AUG-1997
           Cleared Under Department of Defense

BK980031   Defense Blood Standard System
                5205 Leesburg Pike
                Suite 1000
                Falls Church, VA 22041
           Trade Name:DBSS - 3.00
           Cleared Date: 31-AUG-1998
           Cleared Under Department of Defense

BK070035   Defense Blood Standard System
                5205 Leesburg Pike
                Suite 1000
                Falls Church, VA 22041
           Trade Name:Defense Blood Standard System
                      (DBSS) - 10.0.0
           Cleared Date: 22-MAY-2008

BK970021   Department of Veterans Affairs
                P.O. Box 5000
                VA Hines Medical Center
                Hines, IL 60141
           Trade Name:Vista Blood Bank Software (V5.2)
           Cleared Date: 23-APR-1999

BK060043   Department of Veterans Affairs
                P.O. Box 7008
                Hines, IL 60141-7008
           Trade Name:VistA Blood Establishment Computer
                      Software (VBECS) - 1.0
           Cleared Date: 19-OCT-2006

BK830025   Dia Tech
                2525 Shader Road
                Orlando, FL   328
           Trade Name:DiaCent 2 Automated Cell
                      Washer/Centrifuge
           Cleared Date: 10-JAN-1984
BK840001   Dia Tech
                2525 Shader Road
                Orlando, FL   328
           Trade Name:DIACENT 1, Automated Cell
                      Washer/Centrifuge
           Cleared Date: 19-MAR-1984

BK870007   DiaClin Laboratories, Inc.
                450 10th Circle North
                Nashville, TN 37203
           Trade Name:SEOPF ROP Tray
           Cleared Date: 04-APR-1990

BK970013   Digi-Trax Corporation
                1550 Barclay Boulevard
                Buffalo Grove, IL 60089
           Trade Name:Donor-ID
           Cleared Date: 27-FEB-1998

BK000020   Digi-Trax Corporation
                1550 Barclay Boulevard
                Buffalo Grove, IL 60089
           Trade Name:Digi-Trax Donor-ID - 2.0
           Cleared Date: 20-APR-2000

BK010049   Digi-Trax Corporation
                1550 Barclay Boulevard
                Buffalo Grove, IL 60089
           Trade Name:Donor-ID - 2.2
           Cleared Date: 26-APR-2002

BK850006   Division of Immunologic Oncology
                3900 Reservoir Rd.,NW,Box 63,Med-Den
                Bld
                Washington, DC 20007
           Trade Name:GTU DR/DQ Typing Tray
           Cleared Date: 25-APR-1985

BK980009   Dominion Biologicals Limited
                5 Isnor Drive
                Dartmouth, Nova Scotia Canada B3B1M1
           Trade Name:Coombs Control Cells (IgG Coated)
           Cleared Date: 30-OCT-1998

BK070065   Duley Hopkins and Associates
                1200 Mountain Creek Road
                # 215
                Chattanooga, TN 37405
           Trade Name:Blood Bank Information Management
                      System (BBIMS) - V2.05.01
           Cleared Date: 25-APR-2008

BK030056   Dynal Biotech Ltd
                11 Bassendale Road
                Croft Busines Park
                Bromborough, Wirral, CH62 3QL, United
                Kingdom
           Trade Name:Dynal Reli SSO HLA-A Typing Kit
           Cleared Date: 29-JAN-2004

BK030057   Dynal Biotech Ltd
                11 Bassendale Road
                Croft Busines Park
                Bromborough, Wirral, CH62 3QL, United
                Kingdom
           Trade Name:Dynal Reli SSO HLA-B Typing Kit
           Cleared Date: 29-JAN-2004

BK030058   Dynal Biotech Ltd
                11 Bassendale Road
                Croft Busines Park
                Bromborough, Wirral, CH62 3QL, United
                Kingdom
           Trade Name:DYNAL RELI SSO HLA-Cw Typing Kit
           Cleared Date: 29-JAN-2004

BK030059   Dynal Biotech Ltd
                11 Bassendale Road
                Croft Busines Park
                Bromborough, Wirral, CH62 3QL, United
                Kingdom
           Trade Name:Dynal RELI SSO HLA-DQB1 Typing Kit
           Cleared Date: 29-JAN-2004

BK030060   Dynal Biotech Ltd
                11 Bassendale Road
                Croft Busines Park
                Bromborough, Wirral, CH62 3QL, United
                Kingdom
           Trade Name:DYNAL RELI  SSO HLA-DRB Typing
                      System.
           Cleared Date: 29-JAN-2004

BK050012   Dynal Biotech Ltd
                11 Bassendale Road
                Croft Busines Park
                Bromborough, Wirral, CH62 3QL, United
                Kingdom
           Trade Name:Dynal RELI SSO HLA-DRB1 Typing Kit
                      -
                      For Use as a manual asssay or with
                      the AutoRELI Instrument
           Cleared Date: 18-MAY-2005

BK960041   Dynamic Healthcare Technologies, Inc.
                101 Southhall Lane, Suite 210
                Maitland, FL 32751
           Trade Name:Transfusion Service Mgr.
           Cleared Date: 16-DEC-1997

BK840004   Dynatech Laboratories, Inc.
                900 Slaters Lane
                Alexandria, VA 22314
           Trade Name:MicroBBank 220 Automated
                      Microplate Reader
           Cleared Date: 18-MAY-1984

BK850013   Dynatech Laboratories, Inc.
                900 Slaters Lane
                Alexandria, VA 22314
           Trade Name:MicroBank System
           Cleared Date: 08-OCT-1985

BK840003   E.I. duPont de Nemours & Company
                Medical Products Department
                Wilmington, DE 19898
           Trade Name:DuPont SCD
           Cleared Date: 07-NOV-1984

BK910022   E.I. duPont de Nemours & Company
                Medical Products Department
                Wilmington, DE 19898
           Trade Name:Du Pont Sorvall RC 3B Plus
                      Du Pont Sorvall RC 3C Plus
                      Centrifuge
           Cleared Date: 21-JAN-1992

BK840018   EK Industries, Inc.
                411 Kay Avenue
                Addison, IL 60101
           Trade Name:Copper Sulfate Solution ( for
                      women)
           Cleared Date: 11-DEC-1984

BK840019   EK Industries, Inc.
                411 Kay Avenue
                Addison, IL 60101
           Trade Name:Copper Sulfate Solution (for men)
           Cleared Date: 11-DEC-1984

BK900006   Electrolux SARL
                1317 F St. NW, suite 150
                Washington, DC 20004
           Trade Name:Blood Chain Thermostabilizer
                      RCB42P
           Cleared Date: 18-JUL-1990

BK860018   Engineering & Research Associates, Inc.
                500 North Tucson Boulevard (ERA
                Plaza)
                Tucson, AZ 85716
           Trade Name:SEBRA Model 1150 (Blood Weigth
                      Monitor)
           Cleared Date: 11-JUL-1986

BK860019   Engineering & Research Associates, Inc.
                500 North Tucson Boulevard (ERA
                Plaza)
                Tucson, AZ 85716
           Trade Name:SEBRA Model 1300 (Tube Stripper)
           Cleared Date: 29-SEP-1986


BK870023   Engineering & Research Associates, Inc.
                500 North Tucson Boulevard (ERA
                Plaza)
                Tucson, AZ 85716
           Trade Name:Sebra Model #1500 Centrifuge Cup
                      Blood Bag Holder
           Cleared Date: 25-SEP-1986

BK900025   Engineering & Research Associates, Inc.
                500 North Tucson Boulevard (ERA
                Plaza)
                Tucson, AZ 85716
           Trade Name:SEBRA Model #2470, Mobile Tube
                      Sealer
           Cleared Date: 26-JUN-1991

BK900026   Engineering & Research Associates, Inc.
                500 North Tucson Boulevard (ERA
                Plaza)
                Tucson, AZ 85716
           Trade Name:SEBRA MODEL #1040, DIGITAL BLOOD
                      SHAKER/WEIGHT MONITOR
           Cleared Date: 26-JUN-1991

BK900029   Engineering & Research Associates, Inc.
                500 North Tucson Boulevard (ERA
                Plaza)
                Tucson, AZ 85716
           Trade Name:Sebra Model #2390, Mobile Tube
                      Sealer
           Cleared Date: 26-JUN-1991

BK910015   Engineering & Research Associates, Inc.
                500 North Tucson Boulevard (ERA
                Plaza)
                Tucson, AZ 85716
           Trade Name:Sebra Model #1290, Blood/Platelet
                      Coolant
           Cleared Date: 11-SEP-1991

BK920002   Ethox Corp.
                251 Seneca St,
                Buffalo, NY 14204
           Trade Name:Ethox Transfer Pack
           Cleared Date: 17-SEP-1992

BK920026   Fenwal Blood Technologies
                25212 W. Illinois Route 120, RLP-34
                Round Lake, Il 60073
                Round Lake, IL 60073
           Trade Name:SDP Microplate Assay Management
                      Software
           Cleared Date: 30-JUL-1993
           Cleared Under Genetic Systems Corporation

BK080018   Fenwal Blood Technologies
                Three Corporate Drive
                Lake Zurich, IL 60047
           Trade Name:Amicus Separator System
           Cleared Date: 26-AUG-2008

BK080033   Fenwal Blood Technologies
                Three Corporate Drive
                Lake Zurich, IL 60047
           Trade Name:PLASMALINK
           Cleared Date: 22-AUG-2008

BK830010   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Transfer Pack  Unit(s) with
                      Sterile Connector
           Cleared Date: 23-AUG-1988
           Cleared Under Travenol Laboratories

BK830011   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Closed Apheresis Kit for Extended
                      Platelet Storage
           Cleared Date: 27-MAY-1983
           Cleared Under Travenol Laboratories

BK830009   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Plasma-Gard
           Cleared Date: 25-JAN-1984
           Cleared Under Travenol Laboratories

BK860015   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Apheresis Kit/Extended Plate.
                      Stor. & Plas. Coll.
           Cleared Date: 03-JUL-1986
           Cleared Under Travenol Laboratories

BK860029   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Isoradial Separation Chamber
           Cleared Date: 28-NOV-1986
           Cleared Under Travenol Laboratories

BK860035   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:CS-3000 Bld Cell Separator Bld
                      Sample Containers
           Cleared Date: 26-FEB-1987
           Cleared Under Travenol Laboratories

BK870017   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Fenwal LS-300 Centrifuge
           Cleared Date: 16-NOV-1987
           Cleared Under Fenwal Laboratories

BK880023   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Fenual CS3000 Blood Cell Separator
           Cleared Date: 13-JUN-1989
           Cleared Under Travenol Laboratories

BK900005   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Closed System Apheresis Kit-
                      CS3000 Blood Cell Separator
           Cleared Date: 05-JUN-1990
           Cleared Under Baxter Healthcare
                Corporation

BK900016   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Closed System Apheresis Kit CS-
                      3000 Blood Cell Separator (single
                      venous access for platelet
                      collection)
           Cleared Date: 07-JUN-1991
           Cleared Under Baxter Healthcare
                Corporation

BK900020   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Optum Platelet Separation Chamber
           Cleared Date: 07-NOV-1990
           Cleared Under Baxter Healthcare
                Corporation

BK910014   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Sepacell R-200; Pre-Storage
                      Leukocyte Depletion Set for Red
                      Blood
           Cleared Date: 18-SEP-1991
           Cleared Under Baxter Healthcare
                Corporation

BK910032   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:OptiPress
           Cleared Date: 03-JUN-1993
           Cleared Under Baxter Healthcare
                Corporation

BK920003   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Fenwal Needle/Tube Sampling
                      Protector/Safety Cover
           Cleared Date: 12-MAR-1992
           Cleared Under Baxter Healthcare
                Corporation

BK920029   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:30-mL Collection Chamber for CS-
                      3000 Plus Blood Cell Separator
           Cleared Date: 06-MAY-1994
           Cleared Under Baxter Healthcare
                Corporation

BK920032   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Sepacell Pre-storage Leukocyte
                      Depletion Set for Red Cell
           Cleared Date: 07-JUN-1993
           Cleared Under Baxter Healthcare
                Corporation

BK920038   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Closed System Apheresis Kit with
                      Integral Leukocyte Removal Filter
           Cleared Date: 27-JUL-1994
           Cleared Under Baxter Healthcare
                Corporation

BK930029   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:AccessTM Management System (AMS)
           Cleared Date: 20-JUN-1994
           Cleared Under Baxter Healthcare
                Corporation

BK940005   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Fenwal Bone Marrow Collection Kit
                      w/ Flexible Pre-filter and Inline
                      Filters and Fenwal Bone Marrow
                      Collection Stand
           Cleared Date: 18-MAY-1994
           Cleared Under Baxter Healthcare
                Corporation

BK940009   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Optipress TM Automated Blood
                      Component
           Cleared Date: 18-MAY-1994
           Cleared Under Baxter Healthcare
                Corporation

BK940013   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Ex Storage PL 732 Containers w/
                      Sepacell Filter for Leukocytes
                      Reduced Platelets
           Cleared Date: 27-JUL-1994
           Cleared Under Baxter Healthcare
                Corporation

BK940023   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Accessory Weight Scale for Medical
                      Purposes
           Cleared Date: 05-JUL-1994
           Cleared Under Baxter Healthcare
                Corporation

BK940036   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Storage Containers for CS-3000
                      Apheresis Kit
           Cleared Date: 27-DEC-1994
           Cleared Under Baxter Healthcare
                Corporation

BK940040   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Sepacell PLS-10A,5A Leukocyte
                      Reduction Filter Platelet Products
           Cleared Date: 28-FEB-1995
           Cleared Under Baxter Healthcare
                Corporation

BK940041   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Sepacell R-2000 Prestorage
                      Leukocyte Reduction Set for Red
                      Blood Cells
           Cleared Date: 14-FEB-1995
           Cleared Under Baxter Healthcare
                Corporation

BK950013   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:CS-3000 Plus (mononeuclear cells)
           Cleared Date: 28-OCT-1998
           Cleared Under Baxter Healthcare
                Corporation

BK950016   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Pall BPF4 Leukocyte Reduction Set
                      for RBC
           Cleared Date: 20-SEP-1995
           Cleared Under Baxter Healthcare
                Corporation

BK950023   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:CS-3000 Blood Cell Separator
                      Apheresis Kit
           Cleared Date: 29-JUN-1995
           Cleared Under Baxter Healthcare
                Corporation

BK960005   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Amicus Separator
           Cleared Date: 19-DEC-1996
           Cleared Under Baxter Healthcare
                Corporation

BK960083   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Hematype Segment Device
           Cleared Date: 28-FEB-1997
           Cleared Under Medical Safety Products,
                Inc.

BK980041   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Sepacell Pre-Storage Leukocyte
                      Reduction Set for Red Cells
           Cleared Date: 16-JUL-1999
           Cleared Under Baxter Healthcare
                Corporation

BK990009   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Fenwal Amicus Separator Collection
                      of Three Platelet Products
           Cleared Date: 03-MAR-2000
           Cleared Under Baxter Healthcare
                Corporation

BK000039   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Amicus Separator, Concurrent
                      Collection of Red Blood Cells
           Cleared Date: 26-AUG-2002
           Cleared Under Baxter Healthcare
                Corporation

BK000047   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Amicus Separator, Mononuclear Cell
                      Collection
           Cleared Date: 31-JUL-2002
           Cleared Under Baxter Healthcare
                Corporation

BK010016   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Apheresis Data Integration System
                      (ADIS)
           Cleared Date: 04-DEC-2001
           Cleared Under Baxter Healthcare
                Corporation

BK010033   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Cygnet System
           Cleared Date: 27-AUG-2002
           Cleared Under Baxter Healthcare
                Corporation

BK020008   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:LeukoConnect - Pre-Storage Sterile
                      Connect Leukoreduction Set with
                      Sepacell Filter for Red Blood
                      Cells
           Cleared Date: 10-DEC-2002
           Cleared Under Baxter Healthcare
                Corporation - I.V. Systems Division

BK020056   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:ALYX System
           Cleared Date: 20-DEC-2002
           Cleared Under Baxter Healthcare
                Corporation

BK030085   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:ALYX Component Collection System
                      and Amicus Separator System
           Cleared Date: 15-MAR-2004
           Cleared Under Baxter Healthcare
                Corporation

BK040059   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:Amicus Separator System
           Cleared Date: 24-SEP-2004
           Cleared Under Baxter Healthcare
                Corporation - Transfusion Therapies
                Division

BK040084   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:ALYX Component Collection System
           Cleared Date: 15-MAR-2005
           Cleared Under Baxter Healthcare
                Corporation

BK050020   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:LeukoConnect - Pre-Storage Sterile
                      Connect Leukoreduction Set with
                      Sepacell Filter for Red Blood
                      Cells in additive solution
           Cleared Date: 17-MAY-2005
           Cleared Under Baxter Healthcare
                Corporation

BK050038   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:AMICUS Separator System
           Cleared Date: 03-NOV-2005
           Cleared Under Baxter Healthcare
                Corporation

BK060061   Fenwal Inc
                25212 W. Illinois Route 120, RLP-34
                Round Lake, IL 60073
           Trade Name:ALYX Component Collection System:
                      ALYX 2RBC-NLR Kit
           Cleared Date: 09-FEB-2007
           Cleared Under Baxter Healthcare
                Corporation

BK080024   Fenwal Inc
                Three Corporate Drive
                3rd Floor
                Lake Zurich, IL 60047
           Trade Name:ALYX Component Collection System
           Cleared Date: 24-JUN-2008

BK080048   Fenwal Inc
                Three Corporate Drive
                3rd Floor
                Lake Zurich, IL 60047
           Trade Name:AMICUS Separator
           Cleared Date: 02-OCT-2008

BK080053   Fenwal Inc
                Three Corporate Drive
                3rd Floor
                Lake Zurich, IL 60047
           Trade Name:ALYX Component Collection System
           Cleared Date: 22-DEC-2008

BK030022   Fresenius Medical Care North America
                6675 185th Avenue NE
                Suite 100
                Redmond, WA 98052
           Trade Name:Fresenius Compomat G4 &
                      Compomaster NT
           Cleared Date: 11-JUL-2003
           Cleared Under Fresenius Hemocare Inc.

BK040005   Fresenius Medical Care North America
                95 Hayden Avenue
                Lexington, MA 02420-9192
           Trade Name:Fresenius Compoguard &
                      Donationmaster NT
           Cleared Date: 26-MAR-2004
           Cleared Under Fresenius Hemocare Inc.

BK040076   Fresenius Medical Care North America
                95 Hayden Avenue
                Lexington, MA 02420-9192
           Trade Name:Compodock
           Cleared Date: 17-DEC-2004
           Cleared Under Fresenius Hemocare Inc.

BK880007   Fresenius USA/Seratronics Inc.
                2637 Shadelands Drive
                Walnut Creek, CA 94598
           Trade Name:Fresenius AS104 Cell Separator
           Cleared Date: 22-JUL-1996

BK880018   Fresenius USA/Seratronics Inc.
                4090 Pike Lane
                Concord, CA 94502
           Trade Name:Astotherm IFT 200; IFT 220
           Cleared Date: 25-AUG-1988

BK960066   Frigidaire Commercial Products Company
                707 Robins St
                Conway, AR 72032
           Trade Name:Eagle Series Blood Storage
                      Refrigerator # ST30RGBB and ST50
           Cleared Date: 30-AUG-1996

BK960092   Fujirebio America Inc.
                30 Two Bridges Road
                Suite 250
                Fairfield, NJ 07004
           Trade Name:Olympus PK CMV-PA System &
                      Controls
           Cleared Date: 28-OCT-1998

BK030007   Fujirebio Diagnostics, Inc.
                201 Great Valley Parkway
                Malvern, PA 19355
           Trade Name:Olympus PK TP System
           Cleared Date: 21-FEB-2003

BK060062   Fujirebio Diagnostics, Inc.
                201 Great Valley Parkway
                Malvern, PA 19355
           Trade Name:Olympus PK® TP Reagent System
           Cleared Date: 25-JUN-2007

BK070030   Fujirebio Diagnostics, Inc.
                201 Great Valley Parkway
                Malvern, PA 19355
           Trade Name:Olympus PK CMV-PA Test System and
                      Controls
                      Olympus PK7300 Automated Blood
                      Bank Analyzer
           Cleared Date: 20-SEP-2007

BK940047   Fujirebio, Inc.
                1129 Bloomfield Ave,
                West Caldwell, NJ 07006
           Trade Name:Olympus PK TP System Reactive
                      Control
           Cleared Date: 29-NOV-1995

BK920005   Futuremed
                2076 Deer Park Avenue
                Deer Park, NY 11729
           Trade Name:AM-4
           Cleared Date: 29-SEP-1994

BK940055   Futuremed
                2076 Deer Park Avenue
                Deer Park, NY 11729
           Trade Name:L Fusion Bags for Warming
                      Blood/Plasma w/ ANIMEC4
           Cleared Date: 27-DEC-1994

BK050018   GE Medical Information Technologies
                540 Northwest Highway
                Barrington, IL 60010
           Trade Name:Centricity Ultra Laboratory
                      Transfusion Medicine (Ultra TM) -
                      4.0
           Cleared Date: 13-JUN-2005

BK040019   GTI, INC
                20925 Crossroads Circle
                Waukesha, WI 53186
           Trade Name:Antibody Monitoring System Class I
                      and Class II (AMS1 and AMS1+2)
           Cleared Date: 06-JUL-2004

BK040034   GTI, INC
                20925 Crossroads Circle
                Waukesha, WI 53186
           Trade Name:Lifecodes LifeScreen:  A Luminex
                      100 Screening Assay  for the
                      Detection of IgG Antibodies to HLA
                      Class I and Class II Molecules of
                      Human Origin
           Cleared Date: 16-JUL-2004

BK040035   GTI, INC
                20925 Crossroads Circle
                Waukesha, WI 53186
           Trade Name:Lifecodes ID Class I:  A Luminex
                      100 screening assay for the
                      qualitative detection of IgG panel
                      reactive antibodies (PRA) to HLA
                      Class I molecules
                      Lifecodes ID Class II:  A Luminex
                      100 screening assay for the
                      qualitative detection of IgG panel
                      reactive antibodies (PRA) to HLA
                      Class II molecules
           Cleared Date: 16-JUL-2004

BK050040   GTI, INC
                20925 Crossroads Circle
                Waukesha, WI 53186
           Trade Name:ThromboType (HPA 1-6, 15) and
                      ThromboType 1 (HPA 1)
           Cleared Date: 20-JAN-2006

BK050054   GTI, INC
                20925 Crossroads Circle
                Waukesha, WI 53186
           Trade Name:GranType(TM)
           Cleared Date: 02-MAR-2006

BK060038   GTI, INC
                20925 Crossroads Circle
                Waukesha, WI 53186
           Trade Name:MICROAMS
           Cleared Date: 28-JUL-2006

BK070034   GTI, INC
                20925 Crossroads Circle
                Waukesha, WI 53186
           Trade Name:HLA EZ Type
           Cleared Date: 10-JUL-2008

BK070045   GTI, INC
                20925 Crossroads Circle
                Waukesha, WI 53186
           Trade Name:Donor Screen HLA Class I and Class
                      II
           Cleared Date: 30-JUL-2008

BK010006   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Trima Automated Blood Component
                      Collection System
           Cleared Date: 27-FEB-2002

BK010037   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Platelet collection sets for the
                      COBE Spectra Apheresis System and
                      the Trima Automated Blood
                      Component Collection System.
           Cleared Date: 09-DEC-2002

BK010046   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Trima Automated Blood Collection
                      System (Single Stage)
           Cleared Date: 18-SEP-2002

BK010050   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Trima Automated Blood Collection
                      System
           Cleared Date: 18-SEP-2002

BK020015   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Vista Information System,
                      Independent Solution
           Cleared Date: 15-JUL-2002

BK020041   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:COBE Spectra Apheresis
                      System/Blood component disposable
                      collection sets for apheresis
           Cleared Date: 23-APR-2003

BK030021   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Vista Information System - 2.1
           Cleared Date: 01-MAY-2003

BK030083   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Trima Accel
           Cleared Date: 14-JAN-2004

BK040069   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Trima Automated Blood Component
                      Collection System - Blood
                      Component Sampling Accessory
           Cleared Date: 28-OCT-2004

BK040086   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:COBE Spectra Apheresis System &
                      Trima Automated Blood Component
                      Collection System
           Cleared Date: 15-MAR-2005

BK070001   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Vista Information System - 3.0
           Cleared Date: 27-JUN-2007

BK070066   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:Vista Information System, Version
                      3.0 with Medical Review Module
           Cleared Date: 13-DEC-2007

BK080010   Gambro BCT, Inc
                10811 W. Collins Ave.
                Lakewood, CO 80215-4498
           Trade Name:The Atreus Whole Blood Processing
                      System
           Cleared Date: 27-JUN-2008

BK870024   Gambro Inc.
                23872 Kelsey Road
                Barrington, IL 60010
           Trade Name:Gambro Welding Device WD2
           Cleared Date: 02-NOV-1987

BK820017   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Omni-Series Control
           Cleared Date: 21-JAN-1983

BK830012   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Omni Coombs Control Cells
           Cleared Date: 13-JUN-1983

BK830014   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Elu-Kit II
           Cleared Date: 25-NOV-1983

BK830019   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Microtear System
           Cleared Date: 21-SEP-1983

BK830026   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Micro-U Plate
           Cleared Date: 08-DEC-1983

BK850001   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma STS-M
           Cleared Date: 05-APR-1985

BK850002   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma STS Red Cell Diluent
           Cleared Date: 05-APR-1985

BK850005   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma STS-A
           Cleared Date: 03-OCT-1986

BK850019   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Micro-U Accessory Equipment
                      (Timer Device)
           Cleared Date: 20-MAR-1986

BK850020   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Micro-U Accessory Equipment
           Cleared Date: 20-MAR-1986

BK850021   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Micro-U Accessory Equipment
           Cleared Date: 20-MAR-1986

BK850024   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Micro-U Coombs Wash Solution
           Cleared Date: 20-MAR-1986

BK850025   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Micro-U Enhancement Reagent
           Cleared Date: 20-MAR-1986

BK860024   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma N-HANCE
           Cleared Date: 26-AUG-1986

BK880016   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:GammaZyme-B
           Cleared Date: 25-AUG-1988

BK900021   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma-clone Control
           Cleared Date: 26-OCT-1990

BK910001   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Peg
           Cleared Date: 24-MAR-1992

BK930026   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma RQC-Kit
           Cleared Date: 16-NOV-1993

BK960055   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Coombs Control Cells (EIgG) Strong
           Cleared Date: 23-OCT-1996

BK960056   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Coombs Control Cells (EIgG) Weak
           Cleared Date: 23-OCT-1996

BK960077   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma Re-ACT Centrifuge
           Cleared Date: 18-SEP-1997

BK960078   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma ReACT Incubator
           Cleared Date: 18-SEP-1997

BK960079   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma ReACT Antibody Detection
                      Strips
           Cleared Date: 18-SEP-1997

BK960080   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma ReACT Diluent
           Cleared Date: 18-SEP-1997

BK960081   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma ReACT Control Cells (EIgG)
           Cleared Date: 18-SEP-1997

BK960090   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma EGA Kit
           Cleared Date: 21-JUL-1997

BK970002   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma-ReACT workstation
           Cleared Date: 30-MAY-1997

BK970003   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Gamma-ReACT Reader
           Cleared Date: 30-MAY-1997

BK970047   Gamma Biologicals, Inc.
                3700 Mangum Road
                Houston, TX 77092
           Trade Name:Olympus System Control Reagent
           Cleared Date: 11-DEC-1998
 

BK060050   Gaymar Industries, Inc.
                1700 Pennsylvania Avenue, N.W.
                Washington, DC 20006-4706
           Trade Name:Medi-Temp III, Model FW600
                      Blood/Fluid Warmer
           Cleared Date: 07-NOV-2006

BK950002   Gen Trak, Inc.
                5100 Campus Dr.
                Plymouth Meeting, NJ 19462
           Trade Name:CQuentials DR DNA Typing Kit
           Cleared Date: 15-MAY-1995

BK000051   Gen-Probe
                10210 Genetic Center Drive
                San Diego, CA 92121-4362
           Trade Name:The Chiron Procleix System
           Cleared Date: 08-FEB-2002

BK010003   Gen-Probe
                10210 Genetic Center Drive
                San Diego, CA 92121-4362
           Trade Name:CHironProcleix HIV-1/HCV Controls
           Cleared Date: 22-FEB-2002

BK010005   Gen-Probe
                10210 Genetic Center Drive
                San Diego, CA 92121-4362
           Trade Name:Chiron Procleix HIV/HCV
                      Proficiency Panel
           Cleared Date: 01-OCT-2001

BK020045   Gen-Probe
                10210 Genetic Center Drive
                San Diego, CA 92121-4362
           Trade Name:Chiron Procleix System
           Cleared Date: 21-NOV-2002

BK050007   Gen-Probe
                10210 Genetic Center Drive
                San Diego, CA 92121-4362
           Trade Name:Procleix System
           Cleared Date: 29-APR-2005

BK050042   Gen-Probe
                10210 Genetic Center Drive
                San Diego, CA 92121-4362
           Trade Name:Procleix System for the Procleix
                      WNV Assay
           Cleared Date: 15-NOV-2005

BK060012   Gen-Probe
                10210 Genetic Center Drive
                San Diego, CA 92121-4362
           Trade Name:Procleix System
           Cleared Date: 15-MAR-2006

BK060021   Gen-Probe
                10210 Genetic Center Drive
                San Diego, CA 92121-4362
           Trade Name:Procleix® TIGRIS® System for use
                      with the Procleix® WNV Assay
           Cleared Date: 20-FEB-2007

BK950018   Genesis BPS, LLC
                65 Commerce Way
                Hackensack, NJ 07601
           Trade Name:TOTAL CONTAINMENT DEVICE (TCD)
           Cleared Date: 14-NOV-1995
           Cleared Under DENCO, INC.

BK880025   Genetic Design Inc.
                7019 Albert Pick Rd.; Suite H
                Greensboro, NC 27409
           Trade Name:HLA-DR Typing Trays
           Cleared Date: 30-DEC-1988

BK870006   Genetic Systems Corporation
                3005 First Avenue
                Seattle, WA 98121
           Trade Name:HLA-B27 Antigen Typing Kit
           Cleared Date: 20-JUL-1987

BK900011   Genetic Systems Corporation
                3005 First Avenue
                Seattle, WA 98121
           Trade Name:Genetic Systems Blood Virus
                      Software
           Cleared Date: 15-MAR-1991

BK930031   Genetic Systems Corporation
                3005 First Avenue
                Seattle, WA 98121
           Trade Name:Expresso Cartridge Software for
                      Blood Virus Applications
           Cleared Date: 24-FEB-1994

BK860022   Genetic Testing Institute
                1701 W. Wisconsin Avenue, Suite 429
                Milwaukee, WI 53233
           Trade Name:GTI-60 HLA Typing Trays
                      GTI-72 HLA Typing Trays
                      GTI-96 HLA Typing Trays
           Cleared Date: 24-FEB-1987

BK910013   Genetic Testing Institute
                1701 W. Wisconsin Avenue, Suite 429
                Milwaukee, WI 53233
           Trade Name:GTI Pep Antibody Enhancement
                      Solution
           Cleared Date: 23-JUN-1992
 

BK930014   Genetic Testing Institute
                1701 W. Wisconsin Avenue, Suite 429
                Milwaukee, WI 53233
           Trade Name:GTI Reduced Wash Elution Kit
           Cleared Date: 28-OCT-1993

BK930032   Genetic Testing Institute
                1701 W. Wisconsin Avenue, Suite 429
                Milwaukee, WI 53233
           Trade Name:GTI ACE Antigen Capture ELISA for
                      Detection of IgG Antibodies to
                      Platelet Specific Antibodies
           Cleared Date: 20-JUN-1994

BK950004   Genetic Testing Institute
                1701 W. Wisconsin Avenue, Suite 429
                Milwaukee, WI 53233
           Trade Name:GTI-PAK 2 Platelet Antibody
                      Screening Kit
           Cleared Date: 15-MAY-1995

BK950005   Genetic Testing Institute
                1701 W. Wisconsin Avenue, Suite 429
                Milwaukee, WI 53233
           Trade Name:GTI-HLA 1, Class I Antibody
                      Screening Kit
           Cleared Date: 19-MAY-1995

BK960059   Genetic Testing Institute
                150 N. Patrick Blvd.
                Brookfield, WI 53045
           Trade Name:PAKAUTO Platelet Antibody
                      Screening Kit
           Cleared Date: 22-OCT-1998

BK980005   Genetic Testing Institute
                150 N. Patrick Blvd.
                Brookfield, WI 53045
           Trade Name:GTI PAT HPA-1 (PI) Genotyping Kit
           Cleared Date: 23-APR-1999

BK000015   Genetic Testing Institute
                150 N. Patrick Blvd.
                Brookfield, WI 53045
           Trade Name:Quick ID Solid Phase ELISA for
                      detection of Panel Reactive HLA
                      Class I IgG Antibodies (PRA)
           Cleared Date: 17-OCT-2000

BK000031   Genetic Testing Institute
                150 N. Patrick Blvd.
                Brookfield, WI 53045
           Trade Name:GTI-MACE (Modified Capture Elisa)
           Cleared Date: 29-JAN-2001

BK990043   Genetic Testing Institute
                150 N. Patrick Blvd.
                Brookfield, WI 53045
           Trade Name:B-Screen Solid Phase ELISA Assay
                      for Detection of IgG Antibodies to
                      HLA Class II Antigens
           Cleared Date: 02-OCT-2000

BK010010   Genetic Testing Institute
                150 N. Patrick Blvd.
                Brookfield, WI 53045
           Trade Name:Quik-ID Class II
           Cleared Date: 01-OCT-2001

BK050026   Greiner Bio One North America, Inc.
                4238 Capital Drive
                Monroe, NC 28110
           Trade Name:Greiner Vacuette No Additive Tubes
           Cleared Date: 07-JUL-2005

BK050028   Greiner Bio One North America, Inc.
                4238 Capital Drive
                Monroe, NC 28110
           Trade Name:Greiner Vacuette Clot Activator
                      Tube
           Cleared Date: 07-JUL-2005

BK030001   Greiner Bio-One GmbH
                4238 Capital Drive
                Monroe, NC 28112
           Trade Name:Greiner Vacuette EDTA K3 Tube
           Cleared Date: 26-FEB-2003

BK030032   Greiner Bio-One GmbH
                4238 Capital Drive
                Monroe, NC 28112
           Trade Name:Vacuette EDTA K2 Tube
           Cleared Date: 18-JUL-2003

BK840002   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Alpha Plasma Pooling Bottle II
           Cleared Date: 13-JUL-1984

BK840007   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Alpha Plasma Pooling Bottle
           Cleared Date: 21-SEP-1984

BK840014   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics V50 Surge Procedure
           Cleared Date: 06-JUL-1984

BK840021   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics PCS Plasma Collection
                      System
           Cleared Date: 03-JAN-1985

BK840022   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics 115 Cell Washer
           Cleared Date: 24-OCT-1984

BK840025   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics 16 Programmed Pump
           Cleared Date: 14-NOV-1984

BK860013   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:603-EX Extended Storage
                      Plateletpheresis Set
           Cleared Date: 06-NOV-1987

BK870026   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics Ultralite Plasma
                      Collection System
           Cleared Date: 17-MAR-1988

BK890007   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics 705 Time Saver
                      Platelet Pack
           Cleared Date: 13-AUG-1990

BK900019   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Alpha Plasma Pooling Bottle II
                      (Significant Rev.)
           Cleared Date: 14-AUG-1990

BK900022   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Plasma Pooling Bottle II
                      (Significant Revision)
           Cleared Date: 11-OCT-1990

BK900027   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:790 ESP Collection Set
           Cleared Date: 19-APR-1991

BK910009   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Alpha Plasma Pooling Bottle II
                      (Significant Rev.)
           Cleared Date: 08-SEP-1991

BK920012   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:705FTSPP/790F
           Cleared Date: 16-SEP-1992

BK920039   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Plasma Collection System PCS2
           Cleared Date: 02-SEP-1993

BK930007   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:790 Extended Storage Platelet
                      Collection Set
           Cleared Date: 16-NOV-1993

BK930008   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:791 A Fresh Frozen Plasma
                      Collection Set (Latham Bowl)
           Cleared Date: 16-NOV-1993

BK930009   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:791 Fresh Frozen Plasma Collection
                      Set (Blow Molded Bowl)
           Cleared Date: 16-NOV-1993

BK930013   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:MCS Plus & Disp.Sets, List No.
                      890,790,791A,791
           Cleared Date: 12-JAN-1994

BK940064   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Red Cell and Plasma Apheresis
                      Set/FOR USE WITH MCP PLUS
           Cleared Date: 23-OCT-1995

BK950001   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics RBC Apheresis Set for
                      MCS+(NO.831)
           Cleared Date: 22-APR-1996

BK950006   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:List #890F Extended Storage Plt
                      Collection Set
           Cleared Date: 09-JUN-1995

BK950007   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:ESP White Cell Filter (No. 790F)
           Cleared Date: 28-JUN-1995

BK950033   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics PCS2
           Cleared Date: 16-APR-1996

BK950034   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Double Product Collection (SDP-3)
           Cleared Date: 15-FEB-1996

BK950063   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Red Blood Cell and Plasma
                      Collection Set for the MCS Plus
                      #823
           Cleared Date: 22-JUL-1996

BK960006   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Double Unit Red Blood Cell
                      Aphersis Set MCS #833
           Cleared Date: 15-OCT-1996

BK960022   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:MCS+Double Unit RBC Apheresis Set-
                      Dry(LN832)
           Cleared Date: 16-APR-1997

BK960023   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:MCS+Red Cell & Plasma Apheresis
                      Set - Dry(LN822)
           Cleared Date: 16-APR-1997

BK960095   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:MCS+Apheresis System (LN8150)
           Cleared Date: 11-APR-1997

BK970029   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Alpha Plasma Pooling Bottle II
                      (60-2227S)
           Cleared Date: 07-JAN-1998
           Cleared Under Alpha Therapeutic
                Corporation

BK970034   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:LN994CF
           Cleared Date: 15-SEP-1998

BK970041   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics Corp. Extended Storage
                      Platelet & Plasma Apheresis Set
                      with Saline Compensation & Pall
                      LRF-XL (LN994C)
           Cleared Date: 16-NOV-1998

BK980040   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Citroflex Plalsticized PVC
                      Extended Storage Platelet Bag
           Cleared Date: 07-JAN-1999

BK000002   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Model 215 Automated
                      Glycerolization and
                      Deglycerolization System
           Cleared Date: 04-MAY-2001

BK990033   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:MCS+ LN8150
           Cleared Date: 20-JAN-2000

BK990044   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics LN832F
                      Two Unit Red Cells Disposable Set
                      with Leukocyte reduction Filter
           Cleared Date: 27-OCT-2000

BK000048   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics LN832F
           Cleared Date: 09-APR-2001

BK010035   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:MCS+ Mobile Collection System
           Cleared Date: 20-DEC-2002

BK020001   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Plasma Pooling Bottle II
           Cleared Date: 29-MAR-2002

BK030031   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics Model 215 Automated
                      Glycerolyzation /
                      Deglycerolyzationand Cell Washing
                      System
           Cleared Date: 10-SEP-2003

BK030062   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics Model 215 Automated
                      Glycerolization/deglycerolization
                      System
           Cleared Date: 10-DEC-2003

BK030084   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics LN994CF-CPP-BA
                      Extended Storage Platelet and
                      Plasma Apheresis Set
           Cleared Date: 09-JAN-2004

BK040001   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics 4mL Sampling System
           Cleared Date: 27-FEB-2004

BK040020   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics LN994CF-BA Extended
                      Storage Platelet and Plasma
                      Apheresis Set with Leukocyte
                      Reduction Filter, and 4 mL
                      Sampling System.
           Cleared Date: 29-MAR-2004

BK040025   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:PCS2 Plasma Collection System
           Cleared Date: 02-JUN-2004

BK040041   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics MCS+8150 Apheresis
                      System
           Cleared Date: 12-JUL-2004

BK040077   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics Model 215 Automated
                      Glycerolization/Deglycerolization
                      System
           Cleared Date: 21-DEC-2004

BK050006   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:ACP 215
                      Glycerolization/Deglycerolization
                      System
           Cleared Date: 14-APR-2005

BK050047   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:MCS+9000, SDP revision E software,
                      994CF-CPP series disposable sets
           Cleared Date: 21-NOV-2005

BK050048   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics MCS+ 8150 Apheresis
                      System
           Cleared Date: 27-SEP-2005

BK060008   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics ACP 215
                      Glycerolization/Deglycerolization
                      System
           Cleared Date: 23-MAY-2006

BK060023   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics MCS+ 8150 Apheresis
                      System
           Cleared Date: 23-MAY-2006

BK060033   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics PCS 2 Plasma
                      Collection System, Wireless (W)
                      Capable Modification-
           Cleared Date: 27-MAR-2008

BK060057   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Cymbal Automated Blood Collection
                      System
           Cleared Date: 28-FEB-2007

BK070019   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Haemonetics PCS2 Plasma Collection
                      System
           Cleared Date: 23-MAY-2007

BK080001   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184-9144
           Trade Name:PCS2 Plasma Collection
                      System_Revision K software
           Cleared Date: 28-MAY-2008

BK080025   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184
           Trade Name:Cymbal Automated Blood Collection
                      System
           Cleared Date: 15-AUG-2008

BK080038   Haemonetics Corporation
                400 Wood Road
                Braintree, MA 02184-9144
           Trade Name:MCS+ 9000 System
           Cleared Date: 04-SEP-2008

BK000037   Harvest Technologies
                40 Grissom Road
                Plymouth, MA 02360
           Trade Name:Harvest PRP Separation System
           Cleared Date: 05-FEB-2001

BK050001   Healthcare Management Systems, Inc.
                3102 West End Avenue, Suite 400
                Nashville, TN 37203
           Trade Name:Monitor Blood Administration
                      Module - Release 24.0
           Cleared Date: 28-SEP-2005

BK030049   Healthcare-ID
                1635 Barclay Blvd.
                Buffalo Grove, IL 60089
           Trade Name:Donor-ID - version 2.5
           Cleared Date: 31-OCT-2003

BK060058   Healthcare-ID
                1635 Barclay Blvd.
                Buffalo Grove, IL 60089
           Trade Name:Donor-ID - 3.0
           Cleared Date: 08-FEB-2007

BK820013   Helmer Labs., Inc.
                5415 Distribution Drive
                Fort Wayne, IN 46825
           Trade Name:Platelet Agitator
           Cleared Date: 29-OCT-1982

BK820022   Helmer Labs., Inc.
                5415 Distribution Drive
                Fort Wayne, IN 46825
           Trade Name:Helmer Incubator-Agitator
           Cleared Date: 03-JAN-1983

BK840027   Helmer Labs., Inc.
                5415 Distribution Drive
                Fort Wayne, IN 46825
           Trade Name:Helmer Platelet Agitator  PF108
                      Helmer Platelet Agitator PF54
           Cleared Date: 16-APR-1985

BK850014   Helmer Labs., Inc.
                5415 Distribution Drive
                Fort Wayne, IN 46825
           Trade Name:PLATELET FLATBED AGITATOR MODEL
                      PF456
           Cleared Date: 30-AUG-1985

BK850015   Helmer Labs., Inc.
                5415 Distribution Drive
                Fort Wayne, IN 46825
           Trade Name:Helmer Incubator Models PC1000
                      Helmer Incubator Models PC2000
                      Helmer Incubator Models PC3000
           Cleared Date: 20-SEP-1985

BK850018   Helmer Labs., Inc.
                5415 Distribution Drive
                Fort Wayne, IN 46825
           Trade Name:Tube Stripper
           Cleared Date: 21-OCT-1985

BK940051   Helmer Labs., Inc.
                5415 Distribution Drive
                Fort Wayne, IN 46825
           Trade Name:Helmer Water Plasma Thawer
           Cleared Date: 03-MAR-1995

BK020029   Helmer Labs., Inc.
                15425 Herriman Boulevard
                Noblesville, IN 46060
           Trade Name:UltraCW (with Software version
                      3.13)
           Cleared Date: 04-OCT-2002

BK890028   Hemagen Diagnostics, Inc.
                9033 Red Branch Road
                Columbia, MD 21045
           Trade Name:Olypmus PK CMV System
           Cleared Date: 11-DEC-1989

BK940035   Hemagen Diagnostics, Inc.
                9033 Red Branch Road
                Columbia, MD 21045
           Trade Name:Olympus PK TM CMV System & System
                      Controls
           Cleared Date: 15-JUL-1996

BK950008   Hemasure, Inc.
                140 Locke Drive
                Marlborough, MA 01752
           Trade Name:LeukoNet Pre Storage
                      Leukodepletion Filteration System
           Cleared Date: 28-JUN-1995

BK980014   Hemasure, Inc.
                140 Locke Drive
                Marlborough, MA 01752
           Trade Name:HemaSure r|LS Pre-Storage
                      Leukoreduction Filtration System
                      for Red Blood Cells
                      HemaSure r|LS Pre-Storage
                      Leukoreduction Filtration System
                      with spike for Red Blood Cells
           Cleared Date: 27-MAY-1999

BK070024   Hemerus Medical, LLC
                5000 Township Parkway
                Saint Paul, MN 55110
           Trade Name:LEUKOSEP® HRC-600-C Leukocyte
                      Reduction Filtration System for
                      Red Blood Cells
           Cleared Date: 23-AUG-2007

BK080031   Hemerus Medical, LLC
                5000 Township Parkway
                Saint Paul, MN 55110
           Trade Name:HEMERUS LEUKOSEP HRC-600-C
                      Leukocyte Reduction Filtration
                      System for Red Blood Cells
           Cleared Date: 11-SEP-2008

BK060048   HemoCue AB
                Kuvettgatan 1
                Angelholm, Sweden SE-262 71
           Trade Name:HemoCue Hb 301 System
           Cleared Date: 05-OCT-2006

BK000043   HemoCue, Incorporated
                9229 Cranford Drive
                Potomac, MD 20854
           Trade Name:HemoCue Low Hemoglobin Analyzing
                      System
           Cleared Date: 09-APR-2001

BK030020   HemoCue, Incorporated
                9229 Cranford Drive
                Potomac, MD 20854
           Trade Name:Donor Hemoglobin Checker System
           Cleared Date: 17-APR-2003

BK030067   HemoCue, Incorporated
                9229 Cranford Drive
                Potomac, MD 20854
           Trade Name:HemoCue Donor Hb Checker Control
           Cleared Date: 19-DEC-2003

BK040031   Hemosystem, S.A.
                45, Cours Gouffe
                13006 Marseille, France
           Trade Name:Scansytem bacterial detection
                      device
           Cleared Date: 23-SEP-2004

BK900024   Heraeus Inc.
                111A Corporate Blvd, S.
                Plainfield, NJ 07080
           Trade Name:Cryofuge 6000
           Cleared Date: 05-NOV-1992

BK900015   I. B. G. Systems Inc.
                P.O. Box 5306
                Laytonsville, MD 20882
           Trade Name:Inverness Blood Grouping System
           Cleared Date: 20-SEP-1990

BK920019   I. B. G. Systems Inc.
                P.O. Box 5306
                Laytonsville, MD 20882
           Trade Name:Inverness Automated Antibody
                      Screening System
           Cleared Date: 26-MAR-1993

BK930025   ICU MEDICAL INC
                142 TECHNOLOGY DRIVE
                IRVINE, CA 92718
           Trade Name:Kelsea Clamp Needle Cover & Guide
           Cleared Date: 28-OCT-1993

BK030087   ITL Corporation Pty, Ltd
                41-45 Tennant Street
                Canberra ACT 2609, Australia
           Trade Name:ITL SampLok Sampling Kit
           Cleared Date: 18-FEB-2004

BK980008   ITL Corporation, LTD.
                22 Molonglo Mall
                Fyshwick, Canberra Australia 2609
           Trade Name:Bloodpack Needle Protector (BNP)
           Cleared Date: 07-APR-1998

BK820010   Idas America Ltd.
                Lockview Plaza
                Lockport, NY 14094
           Trade Name:Animec
           Cleared Date: 14-SEP-1982

BK820019   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Checkcell
           Cleared Date: 15-DEC-1982

BK830004   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:22% Bovine Albumin
           Cleared Date: 17-MAR-1983

BK830005   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:30% Bovine Albumin
           Cleared Date: 17-MAR-1983

BK830007   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Low Ionic Strength Solution (LISS)
           Cleared Date: 11-MAY-1983

BK830013   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Rh-Hr Control
           Cleared Date: 19-JUL-1983

BK830021   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Anti-N Lectin
           Cleared Date: 07-NOV-1983

BK830022   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:ImmuAdd
           Cleared Date: 07-NOV-1983

BK830018   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Anti-A1 Lectin
           Cleared Date: 07-NOV-1983

BK840024   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:corQc Test System
           Cleared Date: 08-NOV-1984

BK860017   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture P Solid Phase System
           Cleared Date: 06-OCT-1986

BK880010   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-R (I and II)
           Cleared Date: 03-JUN-1988

BK880011   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-R (Pooled)
           Cleared Date: 03-JUN-1988

BK880014   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Modified Capture-P
           Cleared Date: 08-DEC-1988

BK880015   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-P Platelets Wash & Storage
                      Solution
           Cleared Date: 08-DEC-1988

BK880022   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture P Ready Screen Solid Phase
                      Assay
           Cleared Date: 03-MAY-1989

BK890012   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture- R Ready- Screen (Pooled)
           Cleared Date: 21-JUN-1990

BK890013   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-R Ready-Screen (I&II)
           Cleared Date: 21-JUN-1990

BK890014   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-R Ready-Id
           Cleared Date: 21-JUN-1990

BK890022   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Ficin Solution Reagent Set
           Cleared Date: 26-JAN-1990

BK920033   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:pHix
           Cleared Date: 21-SEP-1993

BK950017   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture S
           Cleared Date: 24-OCT-1997

BK950029   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture - CMV
           Cleared Date: 22-DEC-1995

BK960016   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Hemaglutination/Dilution Strips
           Cleared Date: 04-JUN-1997

BK960017   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Modified Capture-R
           Cleared Date: 30-JUN-1998

BK960018   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:ABS QC Test System/ABS QC Test
                      System Plus
           Cleared Date: 21-JUL-1997

BK960019   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:ABS2000
           Cleared Date: 30-JUN-1998

BK960020   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture -R Control Cells
           Cleared Date: 04-JUN-1997

BK000021   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name: Capture-S Solid Phase Assay
           Cleared Date: 22-JUN-2000

BK000024   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:ABS2000, Version 2 software
                      (2.05.00A and 2.05.00B)
           Cleared Date: 03-JUL-2001

BK010002   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:ABS2000 (version 1.00.30A SR-1)
           Cleared Date: 16-FEB-2001

BK010020   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:ABS2000 with Version 2.05.00A
                      Software
                      ABS2000 with Version 2.05.00B
                      Software
                      ABS2000 with Version1.00.30A SR-2
                      Software
           Cleared Date: 24-SEP-2001

BK020053   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-R Ready Indicator Red
                      Cells
           Cleared Date: 27-JAN-2003

BK020054   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-R Control Cells
           Cleared Date: 27-JAN-2003

BK040010   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Monoclonal Control
           Cleared Date: 23-APR-2004

BK040013   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Galileo version 1.3.6 SP4
           Cleared Date: 23-APR-2004

BK040014   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Galileo QC Cell
           Cleared Date: 22-APR-2004

BK040023   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:DAT Positive Control Cell
           Cleared Date: 23-APR-2004

BK040024   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-R Select Solid Phase
                      System
           Cleared Date: 28-APR-2004

BK040057   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Check cell (Weak)
           Cleared Date: 06-OCT-2004

BK050050   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Capture-CMV
                      Galileo Automated Blood Bank
                      System
           Cleared Date: 14-NOV-2005

BK060009   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Galileo Automated Blood Bank
                      System with Capture-S Syphilis
                      Screening Assay
           Cleared Date: 11-APR-2006

BK060016   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:corQC Test System
           Cleared Date: 09-MAY-2006

BK070013   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Monoclonal Control
           Cleared Date: 14-JUN-2007

BK070014   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:DAT Positive Control Cell
           Cleared Date: 14-JUN-2007

BK070015   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:WB corQC
           Cleared Date: 14-JUN-2007

BK070016   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Galileo Echo Automated Blood Bank
                      System
           Cleared Date: 14-JUN-2007

BK070039   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:corQC Extend
           Cleared Date: 28-SEP-2007

BK070040   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Galileo Automated Blood Bank
                      System with assays to perform red
                      blood cell phenotying
           Cleared Date: 28-SEP-2007

BK070051   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Immucor's WB corQC
           Cleared Date: 16-NOV-2007

BK070054   Immucor, Inc.
                3130 Gateway Drive
                Norcross, GA 30091-5625
           Trade Name:Galileo with Reverse ABO Group
                      Assay
           Cleared Date: 30-NOV-2007

BK910033   In-Touch Company
                101 N 700 West
                Salt Lake City, UT 84954
           Trade Name:Alton Dean Model 537 Blood Warmer
           Cleared Date: 18-NOV-1992

BK960068   Indico, Inc.
                Suite 137
                6325 103 Street
                Edmonton, ALBERTA Canada T6H 5H6
           Trade Name:RadTag
           Cleared Date: 30-OCT-1996

BK000008   Indico, Inc.
                Suite 137
                6325 103 Street
                Edmonton, ALBERTA Canada T6H 5H6
           Trade Name:RadTag
           Cleared Date: 01-MAR-2000

BK950064   Informatics
                4000 Kruso Way Place
                Building 3 Suite 210
                Lake Oswego, OR 97035
           Trade Name:Lifeline Blood Bank Data
                      Management System, Release 4.2
           Cleared Date: 01-JUL-1998

BK950032   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:Abbott Data Management System,
                      version 3.0.2
           Cleared Date: 18-AUG-1998
           Cleared Under Abbott Laboratories

BK950037   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:Components& Distribution
                      Information System (CDIS)
           Cleared Date: 26-AUG-1996

BK950045   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:DONOR MANAGEMENT INFORMATION
                      SYSTEMS
           Cleared Date: 26-AUG-1996

BK980020   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:Plasma Center Management System -
                      Version 1.0
           Cleared Date: 31-JUL-1998
 

BK980028   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:PCMS - version 1.1
           Cleared Date: 04-SEP-1998

BK990016   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:Surround System - 1.0
           Cleared Date: 27-AUG-1999

BK990029   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:Plasma Center Management System
                      (PCMS) Version 1.2
           Cleared Date: 13-OCT-1999

BK000016   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:Information Data Management
                      Surround System - 2.0
           Cleared Date: 07-APR-2000

BK990046   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:Plasma Center Management System
                      (PCMS) - Version 2.0
           Cleared Date: 06-JAN-2000

BK010028   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:IDM Surround System - 3.0
           Cleared Date: 05-SEP-2001

BK020038   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:Surround System, Version 3.2
           Cleared Date: 08-OCT-2002

BK050014   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:IDM Prelude System, Version 1.1
           Cleared Date: 18-JUL-2005

BK070031   Information Data Management, Inc.
                9701 West Higgins Road
                Rosemont, IL 60018
           Trade Name:IDM Symphony System - 2.0
           Cleared Date: 13-DEC-2007

BK860042   Insta Cool, Inc of North America
                11300 Sanders Drive, Suite 14
                Rancho Cordova, CA 95742
           Trade Name:Insta Cool Model BP2502
           Cleared Date: 04-MAR-1987

BK900032   Insta Cool, Inc of North America
                11300 Sanders Drive, Suite 14
                Rancho Cordova, CA 95742
           Trade Name:MP III
           Cleared Date: 30-MAR-1992

BK910011   Insta Cool, Inc of North America
                11300 Sanders Drive, Suite 14
                Rancho Cordova, CA 95742
           Trade Name:MT-200 FROZEN PLASMA THAWER
           Cleared Date: 19-DEC-1991

BK940019   Insta Cool, Inc of North America
                11300 Sanders Drive, Suite 14
                Rancho Cordova, CA 95742
           Trade Name:Hemopharm PB-500 Pocket Sealer
           Cleared Date: 26-SEP-1994

BK850016   Integrated Diagnostics, Inc.
                1901 Sulphur Spring Road
                Baltimore, MD 1227
           Trade Name:HLA COMPREHENSIVE TRAY
           Cleared Date: 30-DEC-1985

BK870018   Integrated Diagnostics, Inc.
                1901 Sulphur Spring Road
                Baltimore, MD 1227
           Trade Name:INDX HLA-DR, DQ Lymphocyte
                      Phenotyping Tray
           Cleared Date: 28-OCT-1987

BK080006   IntelliDOT Corporation
                13520 Evening Creek Drive North,
                Suite 400
                San Diego, CA 92128
           Trade Name:IntelliDOT Blood Product
                      Administration
           Cleared Date: 13-JUN-2008

BK820001   International Business Machines

                Princeton, NJ 08540
           Trade Name:IBM 2991
           Cleared Date: 28-JUN-1982

BK830003   International Business Machines

                Princeton, NJ 08540
           Trade Name:IBM 2991 - Single Unit Leukocytes
                      from Whole Blood
           Cleared Date: 27-MAY-1983

BK830020   International Business Machines

                Princeton, NJ 08540
           Trade Name:Plastic for  2997
                      Plastic for 2991
           Cleared Date: 27-OCT-1983

BK830024   International Business Machines

                Princeton, NJ 08540
           Trade Name:Plastic for 2991
                      Plastic for 2997
           Cleared Date: 09-MAR-1984

BK820020   International Equipment Company
                300 Second Avenue
                Needham Heights, MA 02194
           Trade Name:IEC Centra-W Cell Washer
           Cleared Date: 05-APR-1983

BK940004   International Equipment Company
                300 Second Avenue
                Needham Heights, MA 02194
           Trade Name:Seromax
           Cleared Date: 08-APR-1994

BK910018   International Specialty Products
                1361 Alps Road
                Wayne, NJ 07470
           Trade Name:RAD-SURE BLOOD IRRADIATION LABEL
           Cleared Date: 12-MAR-1992

BK920035   International Specialty Products
                1361 Alps Rd,
                Wayne, NJ 07470
           Trade Name:RAD-Sure 2500
           Cleared Date: 01-APR-1993

BK070038   Invitrogen Corporation
                9099 North Deerbrook Trail
                Brown Deer, WI 53223
           Trade Name:AllSet Gold SSP
           Cleared Date: 26-SEP-2007

BK070041   Invitrogen Corporation
                9099 North Deerbrook Trail
                Brown Deer, WI 53223
           Trade Name:DynaChip HLA Antibody Analysis
                      System
           Cleared Date: 30-APR-2008

BK070046   Invitrogen Corporation
                9099 North Deerbrook Trail
                Brown Deer, WI 53223
           Trade Name:UniMatch Plus Version 4.0
           Cleared Date: 27-SEP-2007

BK960054   Jewett Refrigerator Co., Inc.
                2-18 Letchworth Street
                Buffalo, NY 14213-1098
           Trade Name:Jewett Models BPL13,BPL21,BPL25
           Cleared Date: 08-AUG-1996

BK960073   Jewett Refrigerator Co., Inc.
                2-18 Letchworth Street
                Buffalo, NY 14213-1098
           Trade Name:Models BBR17, BBR25,BBR37 &BBR55
           Cleared Date: 30-OCT-1996

BK960089   Jewett Refrigerator Co., Inc.
                2-18 Letchworth Street
                Buffalo, NY 14213-1098
           Trade Name:Jewett Model CT1
           Cleared Date: 06-FEB-1997

BK970001   Jewett Refrigerator Co., Inc.
                2-18 Letchworth Street
                Buffalo, NY 14213-1098
           Trade Name:Jewett Model CTF-1
           Cleared Date: 16-APR-1997

BK970014   Jewett Refrigerator Co., Inc.
                2-18 Letchworth Street
                Buffalo, NY 14213-1098
           Trade Name:Jewett Model BBWM3
           Cleared Date: 18-JUL-1997

BK970028   Jewett Refrigerator Co., Inc.
                2-18 Letchworth Street
                Buffalo, NY 14213-1098
           Trade Name:Jewett Model BPL55
           Cleared Date: 15-OCT-1997

BK860037   Jouan, Inc.
                Route 8,Box 1202;P.O. Box 2716
                Winchester, VA 22601
           Trade Name:Model LR5.22 centrifuge
           Cleared Date: 15-DEC-1986

BK870001   Jouan, Inc.
                Route 8,Box 1202;P.O. Box 2716
                Winchester, VA 22601
           Trade Name:Model GR 4.11 centrifuge
           Cleared Date: 20-FEB-1987

BK890027   Jouan, Inc.
                Route 8,Box 1202;P.O. Box 2716
                Winchester, VA 22601
           Trade Name:Model KR4-22 Centrifuge
           Cleared Date: 02-FEB-1990

BK840005   Kontron Blood Bank Systems
                9 Plymouth Street
                Everett, MA 02149
           Trade Name:Kontron Microgroupamatic
           Cleared Date: 27-JUN-1984

BK870012   Kontron Blood Bank Systems
                9 Plymouth Street
                Everett, MA 02149
           Trade Name:LHS-500 Sampler and Delivery
                      System
           Cleared Date: 02-NOV-1987

BK890008   Kontron Blood Bank Systems
                9 Plymouth Street
                Everett, MA 02149
           Trade Name:G-1000
                      G-2000
                      G-2000 MK II
           Cleared Date: 30-AUG-1989

BK040053   Korchek Technologies, LLC
                770 Plattsville Road
                Trumbull, CT 06611
           Trade Name:CareChek Patient Identification
                      System, CareChek TX - version 1
           Cleared Date: 12-AUG-2005

BK030037   Kowa Company, Ltd.
                c/o Quintiles Consulting
                1801 Rockville Pike, Suite 300
                Rockville, MD 20852
           Trade Name:LD-2000 Leukocyte Counter
           Cleared Date: 14-JUN-2004

BK860031   Lab-Line Instruments, Inc.
                15th and Bloomingdale Avenues
                Melrose Park, IL 60160
           Trade Name:Hema-Bath
           Cleared Date: 02-MAR-1987

BK860023   Level 1 Technologies, Inc.
                160 Weymouth Street
                Rockland, MA 02370
           Trade Name:Level 1 Fluid Warmer
           Cleared Date: 25-SEP-1986

BK920021   Level 1 Technologies, Inc.
                160 Weymouth Street
                Rockland, MA 02370
           Trade Name:A/V Rewarming Procedural Kit
                      Gentilello Technique
           Cleared Date: 29-JAN-1993

BK940056   Level 1 Technologies, Inc.
                160 Weymouth Street
                Rockland, MA 02370
           Trade Name:Level I Fluid Warmer
           Cleared Date: 27-DEC-1994

BK020043   Level 1 Technologies, Inc.
                160 Weymouth Street
                Rockland, MA 02370
           Trade Name:level 1 fluid warming system
           Cleared Date: 16-JUN-2003

BK080017   LifeSouth Community Blood Centers Inc.
                4039 W. Newberry Road
                Gainesville, FL 32607
           Trade Name:Integrated Blood Bank Information
                      System (IBBIS) Registration Module
                      - v1.0
           Cleared Date: 05-AUG-2008

BK830006   Liquid Crystal Products, Inc.
                724 Algonquin Road
                Arlington Heights, IL 60005
           Trade Name:HemoTemp II Blood Temperature
                      Indicator
           Cleared Date: 04-MAY-1983

BK990013   Ljungberg & Kogel
                C/O Kamm & Associates
                P O Box 7007
                Deerfield, IL 60015
           Trade Name:Biomixer 330 & Biomixer 323
           Cleared Date: 07-JUL-1999

BK960050   MAK-System
                Z.I. Paris Nord II
                14, Rue de la Perdrix
                95946 Roissy C.D.G. CEDEX, France
                B.P. 50035
           Trade Name:Progesa
           Cleared Date: 10-DEC-1998

BK060035   MAK-System
                10 Avenue de la Grande Armee
                75017 Paris, France 75017
           Trade Name:Patient Health Software - 1.0
           Cleared Date: 09-MAY-2007

BK070062   MAK-System
                10 Avenue de la Grande Armee
                75017 Paris, France 75017
           Trade Name:PROGESA - 4.4h
           Cleared Date: 26-OCT-2007

BK080002   MAK-System
                10 Avenue de la Grande Armee
                75017 Paris, France 75017
           Trade Name:ePROGESA - 5.0.1
           Cleared Date: 13-MAY-2008

BK960029   MEDITECH Medical Information Technology,
           Inc.
                MEDITECH Circle
                Westwood, MA 02090
           Trade Name:MEDITECH
           Cleared Date: 19-MAR-1999

BK980046   MEDITECH Medical Information Technology,
           Inc.
                MEDITECH Circle
                Westwood, MA 02090
           Trade Name:Magic Client Server - 5.1
           Cleared Date: 08-FEB-2000

BK060029   MEDITECH Medical Information Technology,
           Inc.
                MEDITECH Circle
                Westwood, MA 02090
           Trade Name:MEDITECH MAGIC Blood Bank Software
                      - 4.9
           Cleared Date: 06-FEB-2007

BK080037   MEDITECH Medical Information Technology,
           Inc.
                MEDITECH Circle
                Westwood, MA 02090
           Trade Name:MEDITECH Client Server Blood bank
                      module 5.6 - v5.6
           Cleared Date: 30-OCT-2008

BK080061   MEDIWARE INFORMATION SYSTEMS, INC.
                11711 West 79th Street
                Lenexa, KS 66214
           Trade Name:HCLL Donor
           Cleared Date: 02-DEC-2008

BK970040   MEDSEP Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Medsep Plasma Bag
           Cleared Date: 23-JAN-1998
           Cleared Under MEDSEP Corp.

BK980027   MEDSEP Corporation
                330 Turnbull Canyon Road
                City of Industry, CA 91745
           Trade Name:Transfer/Freezing Bag Set
           Cleared Date: 26-MAR-1999
           Cleared Under MEDSEP Corp.

BK980030   MEDSEP Corporation
                330 Turnbull Canyon Road
                City of Industry, CA 91745
           Trade Name:Medsep Freezing bag
           Cleared Date: 29-AUG-1998
           Cleared Under MEDSEP Corp.

BK980038   MEDSEP Corporation
                330 Turnbull Canyon Road
                City of Industry, CA 91745
           Trade Name:Cell Wash/Infusion Bag Set
           Cleared Date: 13-JUL-1999
           Cleared Under MEDSEP Corp.

BK000032   MEDSEP Corporation
                330 Turnbull Canyon Road
                City of Industry, CA 91745
           Trade Name:Modified Plasma Bag
           Cleared Date: 27-SEP-2000
           Cleared Under MEDSEP Corp.

BK050015   MEDSEP Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Leukotrap SC RC Filtration System
           Cleared Date: 14-APR-2005
           Cleared Under MEDSEP Corp.

BK080003   MEDSEP Corporation
                16 Pepperwood Lane
                Pepper Pike, OH 44124
           Trade Name:Pall Acrodose PLus System,
                      Platelet Pool and Store Set with
                      in-Line Leukocyte Reduction Filter
           Cleared Date: 18-APR-2008

BK930021   MIGADAS INC
                482 Hudson Terrace
                Englewood Cliffs, NY 07632
           Trade Name:Samplink
           Cleared Date: 16-NOV-1993

BK970022   MIGADAS INC
                482 Hudson Terrace
                Englewood Cliffs, NY 07632
           Trade Name:samplink
           Cleared Date: 18-SEP-1997

BK910007   MMED
                609 19th Avenue, S.W.
                Rochester, MN 55902
           Trade Name:MMED Vapor Condensation Blood
                      Warmer
           Cleared Date: 16-MAR-1992

BK910004   MPI/Dupaco, Inc.
                2620 Temple Heights Drive
                Oceanside, CA 92056
           Trade Name:Dupaco Blood/Fluid Warming Cuff
                      Set
           Cleared Date: 21-FEB-1992

BK030008   MacoProductions S.A.S.
                c/o Hoppe Regulatory Consultants
                2335 massey Lane
                Decatur, GA 30033
           Trade Name:Leucolab LCG2 Leukoreduction
                      System for Red Blood Cells
           Cleared Date: 02-MAY-2003

BK050041   MacoProductions S.A.S.
                c/o Hoppe Regulatory Consultants
                2335 massey Lane
                Decatur, GA 30033
           Trade Name:Leucolab LCG2 Leukoreduction
                      System for Red Blood Cells
           Cleared Date: 12-OCT-2005

BK960075   Mallinckrodt Medical, Inc.
                675 McDonnell Boulevard
                St. Louis, MO 63134
           Trade Name:Alton Dean Fluid Warmer, FW-537
           Cleared Date: 28-FEB-1997

BK920031   Medical Marketing Consultants
                3 Bethesda Metro Center,Suite 750
                Bethesda, MD 20814
           Trade Name:sHLA-STAT B27 ELISA for HLA-B27
                      Typing
           Cleared Date: 20-AUG-1993

BK980034   Mediware Information Systems, Inc.
                1121 Old Walt Whitman Road
                Melville, NY 11747
           Trade Name:Hemocare Blood Bank Management
                      System - Revision 5.2
           Cleared Date: 10-DEC-1998

BK010052   Mediware Information Systems, Inc.
                9000 Harry Hines Blvd
                Dallas, TX 75235
           Trade Name:LifeTrak Lab - 2.03
           Cleared Date: 17-JUN-2002

BK020046   Mediware Information Systems, Inc.
                900 Oakmont Lane
                Westmont, IL 60659
           Trade Name:Hemocare LifeLine - Version, 1.0
           Cleared Date: 14-FEB-2003

BK030078   Mediware Information Systems, Inc.
                4545 Fuller Drive, Ste 320
                Irving, TX 75038
           Trade Name:HCLL - 2.6
           Cleared Date: 08-APR-2004

BK040047   Mediware Information Systems, Inc.
                4545 Fuller Drive, Ste 320
                Irving, TX 75038
           Trade Name:Instrument Interface Engine - 1.0
           Cleared Date: 16-JUL-2004

BK050011   Mediware Information Systems, Inc.
                4545 Fuller Drive, Ste 320
                Irving, TX 75038
           Trade Name:HCLL Donor - 1.0
           Cleared Date: 10-MAY-2005

BK060019   Mediware Information Systems, Inc.
                4545 Fuller Drive, Ste 320
                Irving, TX 75038
           Trade Name:Life Trak / Donor - 3.01
           Cleared Date: 21-JUN-2006

BK080049   Mediware Information Systems, Inc.
                1900 Spring Road, Suite 450
                Oak Brook Service Center
                Oak Brook, IL 60523
           Trade Name:HCLL Transfusion, v3.0
           Cleared Date: 22-OCT-2008

BK910019   Medsep Corporation
                2200 Northern Boulevard
                East Hills, NY 11548-1289
           Trade Name:Pall BPF4B Leukocyte Removal Blood
                      Processing Filter wiht Attached
                      Tubing and Blood Bag
           Cleared Date: 16-JAN-1992
           Cleared Under Pall Bio Medical

BK920023   Medsep Corporation
                2200 Northern Boulevard
                East Hills, NY 11548-1289
           Trade Name:Pall Autostop Leukocyte Removal
                      Platelet Filter with Tubing
           Cleared Date: 26-OCT-1992
           Cleared Under Pall Bio Medical

BK940018   Medsep Corporation
                2200 Northern Boulevard
                East Hills, NY 11548-1289
           Trade Name:Pall AutoprocessorTM System
           Cleared Date: 07-SEP-1994
           Cleared Under Pall Bio Medical

BK020014   Medsep Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Pall Bacterial Detection System
                      (BDS)
           Cleared Date: 22-OCT-2002

BK030082   Medsep Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Pall eBDS
           Cleared Date: 04-FEB-2004

BK050034   Medsep Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Pall Acrodose™ PL System, Platelet
                      Pool and Store Set with eBDS
                      Pall Platelet Pool and Store Set
                      with Pall eBDS
           Cleared Date: 28-SEP-2005

BK050074   Medsep Corporation
                16 Pepperwood Lane
                Pepper Pike, OH 44124
           Trade Name:Pall Acrodose PL System
           Cleared Date: 26-JAN-2006

BK050075   Medsep Corporation
                16 Pepperwood Lane
                Pepper Pike, OH 44124
           Trade Name:Pall eBDS
           Cleared Date: 20-DEC-2005

BK060040   Medsep Corporation
                16 Pepperwood Lane
                Pepper Pike, OH 44124
           Trade Name:Pall Acrodose PL System, Platelet
                      Pool and Store Set with in-line
                      Leukocyte Reduction Filter
           Cleared Date: 12-APR-2007

BK060044   Medsep Corporation
                16 Pepperwood Lane
                Pepper Pike, OH 44124
           Trade Name:Pall Acrodose™ PL System, Platelet
                      Pool and Store Set with eBDS
           Cleared Date: 01-SEP-2006

BK060045   Medsep Corporation
                16 Pepperwood Lane
                Pepper Pike, OH 44124
           Trade Name:Pall Acrodose™ PL System, Platelet
                      Pool and Store Set
           Cleared Date: 01-SEP-2006

BK060047   Medsep Corporation
                16 Pepperwood Lane
                Pepper Pike, OH 44124
           Trade Name:Pall eBDS
           Cleared Date: 04-APR-2007

BK070004   Medsep Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Pall eBDS
           Cleared Date: 26-JUN-2007

BK070056   Medsep Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Pall Acrodose PLus System Platelet
                      Pool and Store Set with in-line
                      Leukocyte Reduction Filter and
                      eBDS
           Cleared Date: 27-SEP-2007

BK070057   Medsep Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Pall Acrodose PLus System Platelet
                      Pool and Store Set with in-line
                      Leukocyte Reduction Filter
           Cleared Date: 27-SEP-2007

BK070063   Medsep Corporation
                1630 Industrial Park Street
                Covina, CA 91722
           Trade Name:Pall eBDS
           Cleared Date: 26-JAN-2008

BK010032   Medserv, Inc.
                71 South Bedford Road
                Mount Kisco, NY 10549
           Trade Name:Plasmapheresis Data System III -
                      1.0
           Cleared Date: 05-FEB-2002

BK030040   Medtronic Sofamor Danek
                1800 Pyramid Place
                Memphis, TN 38132
           Trade Name:Magellan Autologous Platelet
                      Separation System
           Cleared Date: 03-SEP-2003

BK040068   Medtronic Sofamor Danek
                1800 Pyramid Place
                Memphis, TN 38132
           Trade Name:Magellan Autologous Platelet
                      Separator System
           Cleared Date: 09-NOV-2004

BK940010   Mercia Diagnostics Limited
                Mercia House, Broadford Park
                Shalford, Guildford GU4 8EW, United
                Kingdom
           Trade Name:CAPTIA TM Syphilis-G
           Cleared Date: 03-JAN-1995

BK920004   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MGR Model ERB-5-0378
           Cleared Date: 12-MAR-1992

BK920013   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Diluent 2
           Cleared Date: 29-SEP-1993

BK920014   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Centrifuge
           Cleared Date: 29-SEP-1993

BK920016   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Buffered Gel Card
           Cleared Date: 29-SEP-1993

BK920030   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Diluent 1
           Cleared Date: 29-SEP-1993

BK930030   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Diluent 2 Plus
           Cleared Date: 12-JAN-1994

BK940034   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Control Card
           Cleared Date: 27-JUL-1994

BK950025   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Incubator
           Cleared Date: 08-MAY-1995

BK950026   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Work Table
           Cleared Date: 15-MAY-1995

BK950027   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:ID-Pipetor
           Cleared Date: 01-JUN-1995

BK950028   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Dispenser (0.5ml and 1.0ml)
           Cleared Date: 27-JUN-1995

BK960013   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS-Centrifuge Model NU 9310
           Cleared Date: 15-APR-1996

BK980016   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:ID-Tipmaster
           Cleared Date: 29-OCT-1998

BK990012   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Reader M
           Cleared Date: 19-NOV-1999

BK000018   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Reader SA
           Cleared Date: 21-NOV-2000

BK010021   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:MTS Incubator II
           Cleared Date: 01-OCT-2001

BK030023   Micro Typing Systems Inc.
                1295 S.W. 29th Ave.
                Pompano Beach, FL 33069
           Trade Name:Ortho ProVue, Software Version:
                      2.10
           Cleared Date: 14-MAY-2003

BK840023   Microdrop, Incorporation
                2227 Corinth Ave.
                Los Angeles, CA 90064
           Trade Name:Leukocyte Typing Serum Trays
           Cleared Date: 12-OCT-1984

BK840013   Microdrop, Incorporation
                2227 Corinth Ave.
                Los Angeles, CA 90064
           Trade Name:Lambda Cell Tray
           Cleared Date: 20-NOV-1984

BK910034   Microwave Medical System
                310-312 School St.
                Acton, MA 01720
           Trade Name:QWIK-1 Bld. and Plasma Warmer
           Cleared Date: 29-JUL-1993

BK940003   Microwave Medical System
                310-312 School St.
                Acton, MA 01720
           Trade Name:Qwik - 1 TM - 500
           Cleared Date: 24-FEB-1994

BK970044   Microwave Medical System
                310-312 School St.
                Acton, MA 01720
           Trade Name:ThermoStat 900
           Cleared Date: 23-JAN-1998

BK970045   Microwave Medical System
                310-312 School St.
                Acton, MA 01720
           Trade Name:ThermoStat 900 Blood & IV Fluid
                      Adm. Set
           Cleared Date: 06-MAR-1998

BK850026   Miles, Inc.
                4th and Parker Streets, P.O. Box 1986
                Berkeley, CA 94701-1986
           Trade Name:Neocel System
           Cleared Date: 22-MAY-1986

BK860006   Miles, Inc.
                4th and Parker Streets, P.O. Box 1986
                Berkeley, CA 94701-1986
           Trade Name:Cutter PPP Harness
           Cleared Date: 17-SEP-1986

BK860016   Miles, Inc.
                4th and Parker Streets, P.O. Box 1986
                Berkeley, CA 94701-1986
           Trade Name:PENTEX MOD-U-CYTE II & VIII
           Cleared Date: 17-APR-1987

BK860028   Miles, Inc.
                4th and Parker Streets, P.O. Box 1986
                Berkeley, CA 94701-1986
           Trade Name:Component Aliquot System
           Cleared Date: 07-DEC-1987

BK900034   Miles, Inc.
                4th and Parker Streets, P.O. Box 1986
                Berkeley, CA 94701-1986
           Trade Name:Phlebotomist Protection Device
           Cleared Date: 27-JAN-1992

BK920027   Miles, Inc.
                4th and Parker Streets, P.O. Box 1986
                Berkeley, CA 94701-1986
           Trade Name:Plasma Pooling Bag
           Cleared Date: 13-APR-1993

BK930001   Miles, Inc.
                4th and Parker Streets, P.O. Box 1986
                Berkeley, CA 94701-1986
           Trade Name:Plasma Sample Vial
           Cleared Date: 20-SEP-1993

BK030065   Mississippi Blood Services, Inc.
                1995 Lakeland Drive
                Jackson, MS 39216
           Trade Name:WebLab Online Laboratory System -
                      2.0
           Cleared Date: 22-DEC-2003

BK040065   Misys Healthcare Systems
                4801 East Broadway Boulevard
                Tucson, AZ 85711
           Trade Name:Misys Laboratory Blood Bank and
                      Blood Donor - 6.0.1
           Cleared Date: 22-OCT-2004

BK060014   Mosum Technology India PVT LTD
                55 Northern Blvd, Suite 200
                Great Neck, NY 11021
           Trade Name:PowerBANK Enterprise Edition -
                      version 1.0
           Cleared Date: 30-MAR-2007

BK920024   Murex Biologicals, Inc.
                1107 I-45 South
                Conroe, TX 77301
           Trade Name:Murex PEG Potentiator for Antibody
                      Detection
           Cleared Date: 01-JUN-1993

BK910016   NPBI
                Runde ZZ 41, 7881 HM Emmer Compascuum
                Emmer-Compascumm, Netherlands
           Trade Name:Compomat
           Cleared Date: 30-MAR-1992

BK930018   NPBI
                Runde ZZ 41, 7881 HM Emmer Compascuum
                Emmer-Compascumm, Netherlands
           Trade Name:Blood Collection Mixer MW 5001
           Cleared Date: 24-JUL-1994

BK930020   NPBI
                Runde ZZ 41, 7881 HM Emmer Compascuum
                Emmer-Compascumm, Netherlands
           Trade Name:Biotrans Separator
           Cleared Date: 27-JUL-1994

BK940061   NPBI
                Runde ZZ 41, 7881 HM Emmer Compascuum
                Emmer-Compascumm, Netherlands
           Trade Name:Composeal Mobile and Composeal
                      Universal
           Cleared Date: 26-JAN-1995

BK950035   NPBI
                Runde ZZ 41, 7881 HM Emmer Compascuum
                Emmer-Compascumm, Netherlands
           Trade Name:Compocool
           Cleared Date: 27-SEP-1995

BK960084   NPBI
                Runde ZZ 41, 7881 HM Emmer Compascuum
                Emmer-Compascumm, Netherlands
           Trade Name:Gambro Hemofreeze Bag
           Cleared Date: 28-MAY-1998

BK950042   National Hospital Specialties
                104 Johnson Avenue
                Hackensack, NJ 07601
           Trade Name:Genesis Blood Collection Mixer
           Cleared Date: 19-SEP-1995

BK840016   Neocyte
                199 Weymouth Street
                Rockland, MA 02370
           Trade Name:NEOPACK System
           Cleared Date: 25-JUN-1985

BK050032   Neoteric Technology Ltd
                205-1099 W. 8th Ave.
                Vancouver, British Columbia Canada
                V6H 1C3
           Trade Name:BloodTrack SafeTx - Version 2.0
           Cleared Date: 16-AUG-2005

BK050059   Neoteric Technology Ltd
                205-1099 W. 8th Ave.
                Vancouver, British Columbia Canada
                V6H 1C3
           Trade Name:BloodTrack Courier - 3.2
           Cleared Date: 13-DEC-2005

BK060041   Neoteric Technology Ltd
                205-1099 W. 8th Ave.
                Vancouver, British Columbia Canada
                V6H 1C3
           Trade Name: BloodTrack - 4.1
           Cleared Date: 12-OCT-2006

BK920020   Nor-Lake, Inc.
                Second and Elm Str. P.O. Box 248
                Hudson, WI 54016
           Trade Name:NSBR211,NSBR482,and NSB763 Blood
                      Refrigerators
           Cleared Date: 19-JAN-1993

BK930002   Nor-Lake, Inc.
                Second and Elm Str. P.O. Box 248
                Hudson, WI 54016
           Trade Name:NSBR61 (Nor-Lake Scientific Blood
                      Bank, 6ft Single Door)
           Cleared Date: 13-APR-1995
BK930003   Nor-Lake, Inc.
                Second and Elm Str. P.O. Box 248
                Hudson, WI 54016
           Trade Name:NSBR83 (Nor-Lake Scientific Blood
                      Bank, 8ft Double Door)
           Cleared Date: 13-APR-1995

BK930004   Nor-Lake, Inc.
                Second and Elm Str. P.O. Box 248
                Hudson, WI 54016
           Trade Name:NSBF211 (Nor-Lake Scientific
                      Freezers, 21ft Single Door)
           Cleared Date: 13-APR-1995

BK930005   Nor-Lake, Inc.
                Second and Elm Str. P.O. Box 248
                Hudson, WI 54016
           Trade Name:NSBF482 (Nor-Lake Scientific
                      Plasma Freezers, 48ft Double Door)
           Cleared Date: 13-APR-1995

BK930006   Nor-Lake, Inc.
                Second and Elm Str. P.O. Box 248
                Hudson, WI 54016
           Trade Name:NSBF61 (Nor-Lake Scientific Plasma
                      Freezer, 6ft Single Door)
           Cleared Date: 13-APR-1995

BK900023   North American Biologicals, Inc.
                16500 N.W. 15th Avenue
                Miami, FL 33169
           Trade Name:QC-HIV
           Cleared Date: 13-NOV-1991

BK910006   North American Biologicals, Inc.
                16500 N.W. 15th Avenue
                Miami, FL 33169
           Trade Name:QC-Hepatitis
           Cleared Date: 12-MAR-1992

BK920015   North American Biologicals, Inc.
                16500 N.W. 15th Avenue
                Miami, FL 33169
           Trade Name:VirocheQC 1
           Cleared Date: 20-MAY-1993

BK910028   North American Technical Services Corp.
                407 E Main St.
                Port Jefferson, NY 11777
           Trade Name:ASTOTHERM/ASTOTUBE
           Cleared Date: 13-JUL-1992

BK930023   Nu-Quest, Inc.
                1031 Meadowview Drive
                Webb City, MO 64870
           Trade Name:Little Pig Sticker
           Cleared Date: 24-FEB-1994
BK830017   Nuclear-Medical Laboratories, Division
                1800 Hurd Drive
                Irving, TX 75061
           Trade Name:Hepa-SHure
           Cleared Date: 07-OCT-1983

BK010040   Olympus America Inc., Diagnostic Systems
           Division
                3131 West Royal Lane
                Irving, TX 75063-3104
           Trade Name:Olympus PK 7200 Automated
                      Microplate System
           Cleared Date: 25-OCT-2001

BK020024   Olympus America Inc., Diagnostic Systems
           Division
                3131 West Royal Lane
                Irving, TX 75063-3104
           Trade Name:Olympus PK7200 Automated
                      Microplate System
           Cleared Date: 08-JUL-2002

BK030009   Olympus America Inc., Diagnostic Systems
           Division
                3131 West Royal Lane
                Irving, TX 75063-3104
           Trade Name:Olympus PK7200 Automated
                      Microplate System
           Cleared Date: 03-MAR-2003

BK040003   Olympus America Inc., Diagnostic Systems
           Division
                3131 West Royal Lane
                Irving, TX 75063-3104
           Trade Name:Olympus PK7200 Automated
                      Microplate System
           Cleared Date: 06-FEB-2004

BK040070   Olympus America Inc., Diagnostic Systems
           Division
                3131 West Royal Lane
                Irving, TX 75063-3104
           Trade Name:Tango Automated Blood Bank
                      Analyzer System
           Cleared Date: 22-MAR-2005

BK050076   Olympus America Inc., Diagnostic Systems
           Division
                3131 West Royal Lane
                Irving, TX 75063-3104
           Trade Name:TANGO Automated Blood Bank
                      Analyzer System (HW Version 02/SW
                      Version 3.0)
           Cleared Date: 16-DEC-2005

BK060024   Olympus America Inc., Diagnostic Systems
           Division
                3131 West Royal Lane
                Irving, TX 75063-3104
           Trade Name:Olympus Bromelin
                      Olympus PK7300 Automated
                      Microplate System
                      Olympus System Control
           Cleared Date: 14-MAY-2007

BK060034   Olympus America Inc., Diagnostic Systems
           Division
                3131 West Royal Lane
                Irving, TX 75063-3104
           Trade Name:TANGO Automated Blood Bank
                      Analyzer System
           Cleared Date: 28-AUG-2006

BK860004   Olympus Corporation
                4 Nevada Drive
                Lake Success, NY 11042
           Trade Name:Olympus PK7100
           Cleared Date: 14-MAY-1986

BK870025   Olympus Corporation
                4 Nevada Drive
                Lake Success, NY 11042
           Trade Name:Olympus PK7100 Automated Blood
                      Grouping System
           Cleared Date: 09-OCT-1987

BK930024   Olympus Corporation
                4 Nevada Drive
                Lake Success, NY 11042
           Trade Name:Olympus PK7200 Blood Grouping
                      Analyzer
           Cleared Date: 26-JAN-1994

BK910021   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:Lifesource Flash Bag
           Cleared Date: 08-JUN-1992

BK920007   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:Lambda Monoclonal Tray Class I and
                      II
           Cleared Date: 28-DEC-1992

BK920009   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:Anti-B27 FITC Conjugated
                      Monoclonal Antibody
           Cleared Date: 25-MAR-1993

BK960011   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:Lambda Antigen Tray
           Cleared Date: 03-JUL-1997

BK960053   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:Anti-B27 FITC/CD3PE Conjugated
                      Monoclonal Antibody
           Cleared Date: 30-OCT-1996

BK960062   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:Micro SSP HLA Class II DNA Typing
                      Kit
           Cleared Date: 11-FEB-1998

BK980015   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:FlowPRA
           Cleared Date: 23-JUL-1999

BK020055   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:LABTYPE SSO Typing Test
           Cleared Date: 04-FEB-2003

BK030069   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name: LABScreen Products for use with
                      LABScan 100 flow analyzer
           Cleared Date: 31-DEC-2003

BK040049   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:LabType Visual
           Cleared Date: 09-AUG-2004

BK050008   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:LABScreen Software
           Cleared Date: 08-JUL-2005

BK050070   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:HLA Visual Software version 1.0
           Cleared Date: 30-JAN-2006

BK050071   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:HLA Tools Software version 1.0
           Cleared Date: 30-JAN-2006

BK070070   One Lambda, Inc.
                21001 Kittridge St.
                Canoga Park, CA 91303
           Trade Name:HLA Fusion Software v 1.0
           Cleared Date: 10-MAR-2008

BK030036   OriGen BioMedical
                4020 S. Industrial Dr. #160
                Austin, TX 78744
           Trade Name:OriGen Cryostore Freezing Bags
           Cleared Date: 01-OCT-2003

BK820003   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:ORTHO Confidence System
           Cleared Date: 10-AUG-1982

BK820006   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:Simwash
           Cleared Date: 13-APR-1983

BK830023   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:TYTEM Typing and Detection System
           Cleared Date: 08-DEC-1983

BK840017   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:ORTHO Cell Suspension Tube
           Cleared Date: 16-NOV-1984

BK890021   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:Ortho Confidence System
           Cleared Date: 23-OCT-1989

BK920034   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:Ortho BioVue System
           Cleared Date: 09-MAY-1995

BK960003   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:Ortho Summitt System
           Cleared Date: 19-OCT-1998

BK960052   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:Ortho Summit Processor
           Cleared Date: 19-OCT-1998

BK990030   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:Ortho Lab with Ortho Lab IC
                      (Instrument Concentrator)
           Cleared Date: 03-APR-2000

BK050044   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:Genetic Systems HIV-1/HIV-2 PLUS O
                      Ortho Assay Protocol Disk
           Cleared Date: 03-NOV-2006

BK050046   Ortho-Clinical Diagnostics, Inc.
                1001 U.S. Highway 202
                P.O. Box 350
                Raritan, NJ 08869-0606
           Trade Name:Genetic Systems HBsAg EIA 3.0
                      Ortho Assay Protocol Disk
           Cleared Date: 13-JAN-2006

BK070028   Ortho-Clinical Diagnostics, Inc.
                100 Indigo Creek Drive
                Rochester, NY 14626-5101
           Trade Name:VITROS Immunodiagnostic Products
                      Anti-HIV 1+2 Controls
           Cleared Date: 10-APR-2008

BK040017   Orthogen Therapeutics, GmbH
                Graf-Adolf-Str. 43
                D-40210 Dusseldorf, Germany
           Trade Name:Osteokin System
           Cleared Date: 23-JUN-2004

BK820002   Pel-Freez Clinical Systems, LLC
                PO Box 68
                Rogers, AR 72756
           Trade Name:
           Cleared Date: 06-OCT-1982

BK820023   Pel-Freez Clinical Systems, LLC
                PO Box 68
                Rogers, AR 72756
           Trade Name:Leukocyte Typing Serum (Human)
                      (Tray Package)
           Cleared Date: 12-JAN-1983

BK850004   Pel-Freez Clinical Systems, LLC
                9099 N. Deerbrook Trail
                Brown Deer, WI 53223
           Trade Name:Frozen Leukocyte Panel (Human)
           Cleared Date: 01-AUG-1985

BK000019   Pel-Freez Clinical Systems, LLC
                9099 N. Deerbrook Trail
                Brown Deer, WI 53223
           Trade Name:UniTray SSP HLA Typing Kits
           Cleared Date: 29-JAN-2001

BK020068   Pel-Freez Clinical Systems, LLC
                9099 N. Deerbrook Trail
                Brown Deer, WI 53223
           Trade Name:Pel Freez HLA High Resolution SSP
                      UniTray
           Cleared Date: 14-JAN-2003

BK030003   Pel-Freez Clinical Systems, LLC
                9099 N. Deerbrook Trail
                Brown Deer, WI 53223
           Trade Name:UniMatch Plus
           Cleared Date: 25-FEB-2003

BK050055   Perfusion Partners & Associates, Inc.
                6227 Foxfire Lane
                Fort Myers, FL 33912
           Trade Name:GenesisCS Component Concentrating
                      System
           Cleared Date: 13-OCT-2006

BK900018   Polar Products, Inc.
                2808 Oregon Ct. Bldg K-4
                Torrance, CA 90503
           Trade Name:Polar Products' Model MTE-58L
           Cleared Date: 30-AUG-1990

BK060056   Prescott Ideas LLC
                8960 E. Anna Place
                Tucson, AZ 85710
           Trade Name:Antibody Check - 4.1
           Cleared Date: 23-APR-2007

BK010017   Psyche Systems Corp
                Ten Laurel Avenue
                Wellesley, MA 02481
           Trade Name:System Blood Bank (SBB) Software -
                      3.0
           Cleared Date: 04-SEP-2001

BK840020   Queue Systems
                22 Airport Industrial Park Rd., Box
                1901
                Parkersburg, WV 26102
           Trade Name:Cryostar
           Cleared Date: 23-OCT-1984

BK990005   R & D Systems, Inc
                614 McKinley Place N.E.
                Minneapolis, MN 55413
           Trade Name:StatusFlow Pro
           Cleared Date: 21-JUN-1999

BK000035   R & D Systems, Inc
                614 McKinley Place N.E.
                Minneapolis, MN 55413
           Trade Name:R & D Leuko-Reduced RBC Control
           Cleared Date: 13-DEC-2000

BK000036   R & D Systems, Inc
                614 McKinley Place N.E.
                Minneapolis, MN 55413
           Trade Name:R & D Leuko-Reduced Plt Control
           Cleared Date: 13-DEC-2000

BK040012   R & D Systems, Inc
                614 McKinley Place N.E.
                Minneapolis, MN 55413
           Trade Name:R&D Donor Checker Hematology
                      Control
           Cleared Date: 05-MAR-2004

BK040063   R & D Systems, Inc
                614 McKinley Place N.E.
                Minneapolis, MN 55413
           Trade Name:R & D Plasma Hemoglobin Hematology
                      Control
           Cleared Date: 17-SEP-2004

BK910012   ROCHE BIOMEDICAL LABORATORIES, INC.
                112 ORANGE DRIVE
                ELON COLLEGE, NC 27244
           Trade Name:HLA CLASS I PHENOTYPING TRAYS
           Cleared Date: 06-JAN-1992

BK860034   Reagent Laboratory, Inc.
                300 East Ottawa Avenue
                Louisville, KY 40209
           Trade Name:Sodium Chloride 1.3%
           Cleared Date: 01-JUN-1987

BK880029   Revco/Lindberg
                275 Aiken Road
                Asheville, NC 28804
           Trade Name:MBF700 Blood Freezer
           Cleared Date: 16-JUN-1989

BK890023   Revco/Lindberg
                275 Aiken Road
                Asheville, NC 28804
           Trade Name:HLT-20DR-87 Blood Freezer
           Cleared Date: 21-SEP-1990

BK890025   Revco/Lindberg
                275 Aiken Road
                Asheville, NC 28804
           Trade Name:HLT-50V-4BB Blood Refrigerator
           Cleared Date: 02-FEB-1990

BK890026   Revco/Lindberg
                275 Aiken Road
                Asheville, NC 28804
           Trade Name:REB3704 Blood Refrigerator
           Cleared Date: 02-FEB-1990

BK950054   Revco/Lindberg
                275 Aiken Road
                Asheville, NC 28804
           Trade Name:Blood Storage Refrigerator REB2304
           Cleared Date: 11-JAN-1996

BK950066   Revco/Lindberg
                275 Aiken Road
                Asheville, NC 28804
           Trade Name:Revco HLT 30V-4BB
           Cleared Date: 31-JAN-1996

BK890006   Rexco
                275 Aiken
                Asheville, NC 28804
           Trade Name:MBF 500 Blood Freezer
           Cleared Date: 16-JUN-1989

BK020018   Roche Molecular Systems, Inc.
                4300 Hacienda Drive
                P.O. Box 9002
                Pleasanton,, CA 94588-0900
           Trade Name:Cobas Ampliscreen System
           Cleared Date: 26-NOV-2002

BK020025   Roche Molecular Systems, Inc.
                4300 Hacienda Drive
                P.O. Box 9002
                Pleasanton,, CA 94588-0900
           Trade Name:COBAS AmpliScreen Data Output
                      Management System (DOMS) - 1.00.04
           Cleared Date: 10-DEC-2002

BK990008   Rubin & Poor, Inc.
                155 Maplewood Avenue #5
                Maplewood, NJ 07040
           Trade Name:Rubin & Poor Configurable Manual
                      Blot System - 1.0C
           Cleared Date: 29-OCT-1999

BK000030   Rubin & Poor, Inc.
                155 Maplewood Avenue #5
                Maplewood, NJ 07040
           Trade Name:Configurable Laboratory Result
                      Manager (CLRM) - 1.0E
           Cleared Date: 23-NOV-2001

BK030073   Rubin & Poor, Inc.
                155 Maplewood Avenue #5
                Maplewood, NJ 07040
           Trade Name:Configurable Manual Batch Entry -
                      1.1A
           Cleared Date: 14-JAN-2004

BK080028   Rubin & Poor, Inc.
                155 Maplewood Avenue #5
                Maplewood, NJ 07040
           Trade Name:Pool results Manager
           Cleared Date: 03-SEP-2008

BK050045   SCC Soft Computer
                34350 U.S. Highway 19 North
                Palm Harbor, FL 34684
           Trade Name:SoftDonor 4.3 with SoftScape
           Cleared Date: 26-OCT-2005

BK060059   SCC Soft Computer
                34350 U.S. Highway 19 North
                Palm Harbor, FL 34684
           Trade Name:SoftDonor 4.4 with DMSI - 4.4
           Cleared Date: 21-DEC-2006

BK080020   SCC Soft Computer
                5400 Tech Data Drive
                Clearwater, FL 33760
           Trade Name:SoftBank II - v23.2
           Cleared Date: 12-AUG-2008

BK960070   SCIMEDX Corporation
                400 Ford Road
                Denville, NJ 07834
           Trade Name:Olympus PK-TP System Control Set
           Cleared Date: 19-JUN-1997

BK950057   SG Scientific
                5745 SW 75th Street
                #284
                Gainseville, FL 32608
           Trade Name:The Saber (Segment Piercing
                      Device)
           Cleared Date: 13-NOV-1995

BK050052   STEMCO Biomedical, Inc.
                2810 Meridan Parkway
                Suite 148
                Durham, NC 27713
           Trade Name:Aldecount Progenitor Cell
                      Enumeration Kit
           Cleared Date: 02-DEC-2005

BK940017   SangStat Medical Corporation
                6300 Dumbarton Circle
                Freemont, CA 94555
           Trade Name:PRA-STAT Elisa/Panel React Anti-
                      HLA Class I IgG Antibody
           Cleared Date: 27-SEP-1994

BK950009   SangStat Medical Corporation
                6300 Dumbarton Circle
                Freemont, CA 94555
           Trade Name:CROSS STAT
           Cleared Date: 09-MAY-1995

BK970037   SangStat Medical Corporation
                6300 Dumbarton Circle
                Freemont, CA 94555
           Trade Name:PRA-STAT Anti-HLA CLASS I IgG
                      Antibodies/Two Patients per Plate
                      Format
           Cleared Date: 18-NOV-1998

BK940011   Sanguin International
                1020 Sherman Avenue
                Hamden, CT 06514
           Trade Name:Sanguin Medusa 2000
           Cleared Date: 29-SEP-1994

BK960065   Sanguin International
                1020 Sherman Avenue
                Hamden, CT 06514
           Trade Name:Sanguin Medusa 2000 - 3.4
           Cleared Date: 17-DEC-1998

BK980003   Sanguin International
                1020 Sherman Avenue
                Hamden, CT 06514
           Trade Name:Aurora/Fenestra (version 1.0)
           Cleared Date: 29-SEP-1999

BK980039   Sanguin International
                1020 Sherman Avenue
                Hamden, CT 06514
           Trade Name:Medusa 2000 Srimport, Version 1.2
           Cleared Date: 11-JUN-1999

BK010042   Sarstedt, Inc.
                P.O. Box 468
                Newton, NC 28658-0468
           Trade Name:Transwaag KL
           Cleared Date: 12-DEC-2001
BK010045   Sarstedt, Inc.
                P.O. Box 468
                Newton, NC 28658-0468
           Trade Name:Sahara Blood & Plasma Warming
                      Device
           Cleared Date: 21-DEC-2001

BK030006   Sarstedt, Inc.
                P.O. Box 468
                Newton, NC 28658-0468
           Trade Name:Transwaag Disk 01
           Cleared Date: 27-FEB-2003

BK040080   Sarstedt, Inc.
                P.O. Box 468
                Newton, NC 28658-0468
           Trade Name:Sahara-TSC
           Cleared Date: 09-FEB-2005

BK070029   Sarstedt, Inc.
                P.O. Box 468
                Newton, NC 28658-0468
           Trade Name:S-Monovette ACD-A
           Cleared Date: 21-SEP-2007

BK940053   Schiff & Company
                1129 Bloomfield Avenue
                West Caldwell, NJ 07006
           Trade Name:Olympus PK System
           Cleared Date: 29-NOV-1995

BK940029   Scimed Life Systems, Inc.
                6655 Wedgewood Rd.
                Maple Grove, MN 55311
           Trade Name:SCIMED UltraFuse Coron.
                      Infusion/Guidewire Exchange
                      Catheter
           Cleared Date: 15-MAR-1995

BK870011   Seabrook Medical Systems, Inc.
                673 Wilmer Aveune
                Cincinnati, OH 45226
           Trade Name:ECMO-TEMP
           Cleared Date: 14-SEP-1987

BK820005   Separation Science Corporation
                169 Avon Street, P.O. Box 643
                Stratford, CT 06497
           Trade Name:SEPCOR Cell Line Monitor
           Cleared Date: 06-JUL-1982

BK880005   Separation Science Corporation
                169 Avon Street, P.O. Box 643
                Stratford, CT 06497
           Trade Name:Blood Bank Saline, Preserved
           Cleared Date: 09-JUN-1988
 

BK050056   Separation Technology, Inc.
                1096 Rainier Drive
                Altamonte Springs, FL 32714-3855
           Trade Name:UltraChek Reference Controls  -
                      Product Code GLK
                      UltraCritTM Hematocrit Measurement
                      Device - Product Code GKF
           Cleared Date: 12-DEC-2005

BK960036   Shared Medical Systems
                51 Valley Stream Parkway
                Malvern, PA 19355
           Trade Name:SMS BB Transfusion System
           Cleared Date: 12-DEC-1997

BK990018   Shotwell & Carr, Inc.
                3535 Firewheel Drive
                Suite A
                Flower Mound, TX 75028-2628
           Trade Name:Hot Shot Fluid Warmer Model 100
                      Hot Shot Fluid Warmer Model 101
                      Hot Shot Fluid Warmer Model 102
                      Hot Shot Fluid Warmer Model 103
           Cleared Date: 13-OCT-1999

BK960051   Siemens Medical Solutions Diagnostics
                800 Dwight Way
                Berkeley, CA 94701-1986
           Trade Name:PPIS - Version 2.0
           Cleared Date: 07-AUG-1998
           Cleared Under Bayer Corporation

BK990024   Siemens Medical Solutions Diagnostics
                800 Dwight Way
                Berkeley, CA 94701-1986
           Trade Name:Plasma Procurement Information
                      System (PPIS) - 3.0
           Cleared Date: 03-NOV-1999
           Cleared Under Bayer Corporation

BK990037   Siemens Medical Solutions Diagnostics
                800 Dwight Way
                Berkeley, CA 94701-1986
           Trade Name:Plasma Procurement Information
                      System (PPIS) - Version 4.0
           Cleared Date: 17-NOV-1999
           Cleared Under Bayer Corporation

BK060015   Siemens Medical Solutions Diagnostics
                P.O. Box 2466
                Berkeley, CA 94702-0466
           Trade Name:TRUGENE HIV-1 Genotyping Kit and
                      OpenGene DNA Sequencing System
           Cleared Date: 21-MAR-2006
           Cleared Under Bayer HealthCare Diagnostics
                Division

BK070009   Siemens Medical Solutions Diagnostics
                P.O. Box 2466
                Berkeley, CA 94702-0466
           Trade Name:TRUGENE HIV-1 Genotyping Kit and
                      OpenGene DNA Sequencing System
           Cleared Date: 19-MAR-2007

BK080036   Siemens Medical Solutions Diagnostics
                P.O. Box 2466
                Berkeley, CA 94702-0466
           Trade Name:TRUGENE HIV-1 Genotyping Kit and
                      OpenGene DNA Sequencing System
           Cleared Date: 20-OCT-2008 

BK040018   sienna partners
                P.O. Box 103
                Baldwin, MD 21013
           Trade Name:Vacuette EDTA K2 tube; Vacuette
                      EDTA K3 tube
           Cleared Date: 28-JUL-2004

BK040066   sienna partners
                P.O. Box 103
                Baldwin, MD 21013
           Trade Name:Greiner VACUETTE No Additive
                      Evacuated Blood Collection Tubes
                      and Serum Clot Activator Blood
                      Collection Tubes
           Cleared Date: 10-SEP-2004

BK850011   Smithkline Beckman Corp.
                999 West Valley Road
                Wayne, PA 19087
           Trade Name:Accugenics (Tray)
           Cleared Date: 07-AUG-1985

BK850012   Smithkline Beckman Corp.
                999 West Valley Road
                Wayne, PA 19087
           Trade Name:Accugenics (HLA Control Cells)
           Cleared Date: 07-AUG-1985

BK960033   Soft Computer Consultants Inc.
                34350 U.S. HWY 19 N.
                Palm Harbor, FL 34684
           Trade Name:SoftBank II Version 19.1
           Cleared Date: 10-JUL-1998

BK000040   Soft Computer Consultants Inc.
                34350 U.S. HWY 19 N.
                Palm Harbor, FL 34684
           Trade Name:SoftBank II - 21.2
           Cleared Date: 20-APR-2001

BK020006   Soft Computer Consultants Inc.
                34350 U.S. HWY 19 N.
                Palm Harbor, FL 34684
           Trade Name:SoftDonor - 4.1
           Cleared Date: 27-FEB-2003

BK020021   Soft Computer Consultants Inc.
                34350 U.S. HWY 19 N.
                Palm Harbor, FL 34684
           Trade Name:SoftBank II - 22
           Cleared Date: 11-SEP-2002

BK030018   Soft Computer Consultants Inc.
                34350 U.S. HWY 19 N.
                Palm Harbor, FL 34684
           Trade Name:SoftBank II - 23
           Cleared Date: 17-APR-2003

BK040028   Soft Computer Consultants Inc.
                34350 U.S. HWY 19 N.
                Palm Harbor, FL 34684
           Trade Name:SoftBank II with SoftScape - 23
           Cleared Date: 07-MAY-2004

BK040048   Soft Computer Consultants Inc.
                34350 U.S. HWY 19 N.
                Palm Harbor, FL 34684
           Trade Name:SoftBank II  with Database
                      Management System Interface (DMSI)
                      - v23.1
           Cleared Date: 23-AUG-2004

BK970032   Sorvall, Inc.
                31 Pecks Lane
                Newtown, CT 06470
           Trade Name:RC12BP
           Cleared Date: 05-DEC-1997

BK030064   Stemco Biomedical, Incorporated
                2810 Meridian Parkway
                Suite 148
                Durham, NC 27713
           Trade Name:Aldecount Progenitor Cell
                      Enumeration Kit
           Cleared Date: 31-DEC-2003

BK040075   Stemco Biomedical, Incorporated
                2810 Meridian Parkway
                Suite 148
                Durham, NC 27713
           Trade Name:Aldecount Progenitor Cell
                      Enumeration Kit
           Cleared Date: 06-JAN-2005

BK860030   Stephens Scientific
                7 Astro Place Box 1116
                Denville, NJ 07834
           Trade Name:Stephens Scientific Certified
                      Blood Bank Saline
           Cleared Date: 16-DEC-1986

BK870015   Stephens Scientific
                7 Astro Place Box 1116
                Denville, NJ 07834
           Trade Name:Certified Blood Bank Saline,
                      Preserved
           Cleared Date: 02-NOV-1987

BK870016   Stephens Scientific
                7 Astro Place Box 1116
                Denville, NJ 07834
           Trade Name:Certified Saline, Preserved
           Cleared Date: 02-NOV-1987

BK880013   Stericon Inc.
                2315 Gardner Road.
                Broadview, IL 60153
           Trade Name:RCM-10 Pediatric Sized Freezing
                      Bag
           Cleared Date: 09-NOV-1988

BK920022   Stericon Inc.
                2315 Gardner Road.
                Broadview, IL 60153
           Trade Name:MB-30 Empty Plastic Containers
           Cleared Date: 03-JUN-1993

BK990002   Sunquest Information Systems, Inc.
                4801 Broadway Boulevard
                Tucson, AZ 85711
           Trade Name:Flexilab - 5.2
           Cleared Date: 16-AUG-1999

BK990034   Sunquest Information Systems, Inc.
                4801 Broadway Boulevard
                Tucson, AZ 85711
           Trade Name:FlexiLab Blood Bank and Blood
                      Donor System - Version 5.2
           Cleared Date: 17-NOV-1999

BK080021   Sunquest Information Systems, Inc.
                250 S. Williams Blvd.
                Tucson, AZ 85711
           Trade Name:Sunquest Transfusion Manager -
                      v1.0
           Cleared Date: 03-DEC-2008

BK960034   SysTec Computer Associates, Inc.
                738 Smithtown Bypass
                Smithtown, NY 11787
           Trade Name:Lifetec Comm. Blood Center System-
                      Rev 2.10
           Cleared Date: 28-JUL-1998

BK990003   SysTec Computer Associates, Inc.
                28 North Country Road
                Mt. Sinai, NY 11766
           Trade Name:LifeTec - 2.20
           Cleared Date: 30-JUL-1999

BK040026   SysTec Computer Associates, Inc.
                28 North Country Road
                Mt. Sinai, NY 11766
           Trade Name:LifeTec Donor Verification and
                      Collection System (DOVAC) - 1.00
           Cleared Date: 21-OCT-2004

BK060032   SysTec Computer Associates, Inc.
                28 North Country Road
                Mt. Sinai, NY 11766
           Trade Name:LifeTec Elite - 1.0
           Cleared Date: 15-AUG-2006

BK970012   Tahoe Chemical R & D
                2230 Damon Road
                Carson City, NV 89701
           Trade Name:Nover Trip Scale Alarm
           Cleared Date: 14-JUL-1997

BK040062   Talisman Ltd.
                421 Church Street NE. Suite F
                Vienna, VA 22180
           Trade Name:Quality Donor System 2004 - 2.0
           Cleared Date: 18-OCT-2004

BK060031   Talisman Ltd.
                421 Church Street NE. Suite F
                Vienna, VA 22180
           Trade Name:Talisman Phlebotomy System Release
                      1.0
           Cleared Date: 27-JUL-2006

BK070020   Talisman Ltd.
                421 Church Street NE. Suite F
                Vienna, VA 22180
           Trade Name:Quality Donor System - v2.1
           Cleared Date: 16-JUL-2007

BK980021   Talon Medical, Ltd.
                18160 Highway 281 N
                Suite 108
                San Antonio, TX 78232
           Trade Name:Cord-X System
           Cleared Date: 20-JAN-1999

BK050003   Tepnel Lifecodes Corporation
                550 West Avenue
                Stamford, CT 06902
           Trade Name:LIFECODES HLA-A Typing Kit for use
                      with Luminex 100, LIFECODES HLA-B
                      Typing Kit for use with Luminex
                      100, HLA-C Typing Kit for use with
                      Luminex 100
                      LIFECODES HLA-DQB Typing Kit for
                      use with Luminex 100  and
                      LIFECODES HLA-DRB Typing Kit for
                      use with Luminex 100
           Cleared Date: 18-JUL-2005

BK080050   Tepnel Lifecodes Corporation
                550 West Avenue
                Stamford, CT 06902
           Trade Name:LIFECODES HLA Typing Kits (HLA-A,
                      B, C, DQB, DRB, DRB1) for use with
                      Luminex
           Cleared Date: 13-NOV-2008

BK820015   Terumo Corporation
                2805 East Ana Street
                Compton, CA 90221
           Trade Name:Plasmaflex Pooling Bottle
           Cleared Date: 12-NOV-1982

BK850017   Terumo Corporation
                2805 East Ana Street
                Compton, CA 90221
           Trade Name:Plasmaflex Bottles
           Cleared Date: 04-NOV-1985

BK860012   Terumo Corporation
                2805 East Ana Street
                Compton, CA 90221
           Trade Name:Imugard Leukocyte Filter
           Cleared Date: 16-MAY-1990

BK890005   Terumo Corporation
                2805 East Ana Street
                Compton, CA 90221
           Trade Name:Stericell Cell Processor
           Cleared Date: 10-OCT-1989

BK890017   Terumo Corporation
                2805 East Ana Street
                Compton, CA 90221
           Trade Name:Teruflex Transfer Bag
           Cleared Date: 18-JUL-1990

BK890032   Terumo Corporation
                125 Blue Ball Road
                Elkton, MD 21921
           Trade Name:Immugard-E- Leukocyte Removal From
                      Red Blood Cells
           Cleared Date: 18-JUL-1990

BK900028   Terumo Corporation
                2805 East Ana Street
                Compton, CA 90221
           Trade Name:Terufusion Plasma Transfer Set
           Cleared Date: 22-OCT-1990

BK920040   Terumo Corporation
                2805 East Ana Street
                Compton, CA 90221
           Trade Name:Venoject II Holder
           Cleared Date: 20-MAY-1993

BK950039   Terumo Corporation
                2100 Cottontail Lane
                Somerset, NJ 08873
           Trade Name:Teruflex B-600 Terumo Blood Bag
                      without anticoagulant
           Cleared Date: 25-AUG-1995

BK950058   Terumo Corporation
                2100 Cottontail Lane
                Somerset, NJ 08873
           Trade Name:Terumo Sampling Site Coupler
           Cleared Date: 13-NOV-1995

BK860041   Terumo Medical Corporation
                125 Blue Ball Road
                Elkton, MD 21921
           Trade Name:SCD 312
           Cleared Date: 01-JUN-1987

BK970008   Terumo Medical Corporation
                125 Blue Ball Road
                Elkton, MD 21921
           Trade Name:Terumo Sterile Tubing Welder SC-
                      201A (TSCD)
           Cleared Date: 28-MAY-1998

BK970011   Terumo Medical Corporation
                125 Blue Ball Road
                Elkton, MD 21921
           Trade Name:Terumo Phlebotomy Needle Cap
                      Holder
           Cleared Date: 19-JUN-1997

BK000045   Terumo Medical Corporation
                125 Blue Ball Road
                Elkton, MD 21921
           Trade Name:Imugard III-PL
           Cleared Date: 28-SEP-2001

BK020033   Terumo Medical Corporation
                125 Blue Ball Road
                Elkton, MD 21921
           Trade Name:Imugard III-PL Leukocyte reduction
                      filter
           Cleared Date: 22-MAY-2003

BK040082   Terumo Medical Corporation
                125 Blue Ball Road
                Elkton, MD 21921
           Trade Name:TSCD-II Terumo Sterile Tubing
                      Welder
           Cleared Date: 05-APR-2005

BK070018   Terumo Medical Corporation
                125 Blue Ball Road
                Elkton, MD 21921
           Trade Name:TRUCISE Total System
           Cleared Date: 22-JAN-2008

BK980002   Teva Medical LTD
                482 Hudson Terrace
                Englewood Cliffs, NJ 07632
           Trade Name:SegMed
           Cleared Date: 02-MAR-1998

BK060060   Texas BioGene, Inc.
                635 Presidential Drive
                Richardson, TX 75081
           Trade Name:Morgan HLA SSP ABDR Typing Kit
           Cleared Date: 22-MAR-2007

BK050058   The Surgical Company International
                Terminalweg 19a
                Amersfoort, Netherlands 3821 AJ
           Trade Name:Fluido Blood and Fluid Warmer
                      System
           Cleared Date: 05-MAY-2006

BK070055   The Surgical Company International
                Terminalweg 19a
                Amersfoort, Netherlands 3821 AJ
           Trade Name:Fluido Air Guard
                      Fluido Compressor
                      Fluido IV-Pole
                      Fluido Pressure Chamber
           Cleared Date: 15-JAN-2008

BK950067   Thermal Transfer Technology
                681 Main Street
                Placerville, CA 95667
           Trade Name:Thermal Ware
           Cleared Date: 14-FEB-1996

BK960072   Thermogenesis
                3146 Gold Camp Drive
                Suite 206
                Rancho Cordova, CA 95670-6022
           Trade Name:CryoSeal System
           Cleared Date: 12-FEB-1999

BK960074   Thermogenesis
                3146 Gold Camp Drive
                Suite 206
                Rancho Cordova, CA 95670-6022
           Trade Name:HemoMatic Blood Collection Monitor
           Cleared Date: 03-APR-1997

BK030011   Thermogenesis
                3146 Gold Camp Drive
                Suite 206
                Rancho Cordova, CA 95670-6022
           Trade Name:ThermoGenesis Thawer
           Cleared Date: 10-JUN-2003

BK070006   Thermogenesis
                2711 Citrus Road
                Rancho Cordova, CA 95742
           Trade Name:AXP AutoXpress Platform
           Cleared Date: 05-OCT-2007

BK900017   Thermopol Inc.
                2481 B Delta Ln,
                Elk Grove Village, IL 60007
           Trade Name:Solid State Portable Refrigerator
           Cleared Date: 30-AUG-1990

BK940038   Thomson & Neilsen, Ltd.
                1050 Baxter Road
                Ottawa, Ontario, Canada, Canada
           Trade Name:Blood Irradiator Dosimetry System
                      TN-ID-50
           Cleared Date: 18-OCT-1994

BK850007   Trayser, Inc.
                P.O. Box 83
                Cabin John, MD 20818
           Trade Name:Trayser DR/DQ Typing Tray Kit
           Cleared Date: 25-APR-1985

BK070037   Typenex Medical LLC
                303 East Wacker Drive
                Suite 311
                Chicago, IL 60601
           Trade Name:TypeSafe Segment Dispenser
           Cleared Date: 05-OCT-2007

BK820012   UCLA Tissue Typing Laboratory
                1000 Veteran Avenue
                Los Angeles, CA 90024
           Trade Name:HLA Typing Tray
           Cleared Date: 04-MAR-1983

BK970026   Utah Medical Products, Inc.
                7043 South 300 West
                Midvale, UT 84047
           Trade Name:Umbilicup
           Cleared Date: 28-JAN-1998

BK970027   Utah Medical Products, Inc.
                7043 South 300 West
                Midvale, UT 84047
           Trade Name:Umbilicup II Cord Blood System
           Cleared Date: 06-JAN-1998

BK010043   VEEGEE Scientific
                13600 NE 126th Place
                Suite A
                Kirkland, WA 98034
           Trade Name:Atago SP-D2 Refractometer
           Cleared Date: 02-JAN-2002

BK870008   Val Tech Diagnostics
                14 Werner Camp Road
                Pittsburgh, PA 15238
           Trade Name:Normal Saline-Buffered
           Cleared Date: 31-JUL-1987

BK880004   Val Tech Diagnostics
                14 Werner Camp Road
                Pittsburgh, PA 15238
           Trade Name:Buffered Normal Saline Concentrate
           Cleared Date: 11-APR-1988

BK070044   Verax Biomedical Incorporated
                377 Plantation St., Biotech 4
                Worcester, MA 01605
           Trade Name:Platelet PGD Controls
                      Platelet PGD Test
           Cleared Date: 17-SEP-2007

BK020005   Visible Genetics, Inc.
                700 BAY Street, Suite 1000
                Toronto, Ontario  M5G 1Z6 Canada
           Trade Name:Trugene HIV-1 Genotyping Kit and
                      Open Gene DNA Sequencing System
           Cleared Date: 24-APR-2002

BK020042   Visible Genetics, Inc.
                700 BAY Street, Suite 1000
                Toronto, Ontario  M5G 1Z6 Canada
           Trade Name:TRUGENE HIV-1 Genotyping Kit and
                      OpenGene DNA Sequencing System
           Cleared Date: 07-NOV-2002

BK030015   Visible Genetics, Inc.
                700 BAY Street, Suite 1000
                Toronto, Ontario  M5G 1Z6 Canada
           Trade Name:TRUGENE HIV-1 Genotyping Kit and
                      OpenGene DNA Sequencing System
           Cleared Date: 14-MAR-2003

BK910010   WHITTAKER BIOPRODUCTS, INC.
                8830 Biggs Ford Road
                Walkersville, MO 21793
           Trade Name:ENDOTOXIN CHALLENGE VIALS
           Cleared Date: 09-AUG-1991

BK860039   Wako Chemicals, USA, Inc.
                12300 Ford Road, Suite 130
                Dallas, TX 75234
           Trade Name:Toxinometer ET-201
           Cleared Date: 10-FEB-1987

BK910005   Whitman Medical Corporation
                990 Raritan Road
                Clark, NJ 07066
           Trade Name:Safe-T-Vue Irreversible
                      Temperature Indicator
           Cleared Date: 12-MAY-1992

BK950059   Wyndgate Technologies
                11121 Sun Center Drive
                Suite C
                Rancho Cordova, CA 95670
           Trade Name:Safe Trace
           Cleared Date: 14-APR-1997

BK980023   Wyndgate Technologies
                11060 White Rock Road
                Suite 200
                Rancho Cordova, CA 95670
           Trade Name:SafeTrace TX, version 1.0
           Cleared Date: 29-JAN-1999

BK070010   Wyndgate Technologies
                4925 Robert J. Matthews Parkway
                Suite 100
                El Dorado Hills, CA 95762
           Trade Name:ElDorado Donor Doc - 1.0.0
           Cleared Date: 23-MAY-2007

BK070064   Wyndgate Technologies
                4925 Robert J. Matthews Parkway
                Suite 100
                El Dorado Hills, CA 95762
           Trade Name:ElDorado Donor - 1.0.0
           Cleared Date: 13-FEB-2008

BK020020   ZLB Behring AG
                Wankdorfstrasse 10
                Postfach 3000 Bern 22, Switzerland
           Trade Name:System for Plasma Identification
                      (SPI) - 1.0
           Cleared Date: 30-OCT-2002

BK050078   ZLB Behring AG
                Wankdorfstrasse 10
                Postfach 3000 Bern 22, Switzerland
           Trade Name:System for Plasma Identification
                      (SPI) - 2.0.0
           Cleared Date: 22-DEC-2005
 
Updated: January 8, 2009