Substantially Equivalent 510(k) Device Applications
Alphabetical Listing by Applicant Name
Information updated through March 31, 2009
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 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 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 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 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 Warsaw, IN 46581-0587 Trade Name:Vortech Concentration System Cleared Date: 21-NOV-2007 BK080004 Biomet Biologics, Inc. P.O. Box 587 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 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 BK960059 Genetic Testing Institute, Inc. (GTI) 20925 Crossroads Circle Sutie 200 Waukesha, WI 53186 Trade Name:PAKAUTO Platelet Antibody Screening Kit Cleared Date: 22-OCT-1998 Cleared Under Genetic Testing Institute 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 02184-9114 Trade Name:Alpha Plasma Pooling Bottle II Cleared Date: 13-JUL-1984 BK840007 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Alpha Plasma Pooling Bottle Cleared Date: 21-SEP-1984 BK840014 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics V50 Surge Procedure Cleared Date: 06-JUL-1984 BK840021 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics PCS Plasma Collection System Cleared Date: 03-JAN-1985 BK840022 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics 115 Cell Washer Cleared Date: 24-OCT-1984 BK840025 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics 16 Programmed Pump Cleared Date: 14-NOV-1984 BK860013 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:603-EX Extended Storage Plateletpheresis Set Cleared Date: 06-NOV-1987 BK870026 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics Ultralite Plasma Collection System Cleared Date: 17-MAR-1988 BK890007 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics 705 Time Saver Platelet Pack Cleared Date: 13-AUG-1990 BK900019 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Alpha Plasma Pooling Bottle II (Significant Rev.) Cleared Date: 14-AUG-1990 BK900022 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Plasma Pooling Bottle II (Significant Revision) Cleared Date: 11-OCT-1990 BK900027 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:790 ESP Collection Set Cleared Date: 19-APR-1991 BK910009 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Alpha Plasma Pooling Bottle II (Significant Rev.) Cleared Date: 08-SEP-1991 BK920012 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:705FTSPP/790F Cleared Date: 16-SEP-1992 BK920039 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Plasma Collection System PCS2 Cleared Date: 02-SEP-1993 BK930007 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:790 Extended Storage Platelet Collection Set Cleared Date: 16-NOV-1993 BK930008 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:791 A Fresh Frozen Plasma Collection Set (Latham Bowl) Cleared Date: 16-NOV-1993 BK930009 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:791 Fresh Frozen Plasma Collection Set (Blow Molded Bowl) Cleared Date: 16-NOV-1993 BK930013 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 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 02184-9114 Trade Name:Haemonetics RBC Apheresis Set for MCS+(NO.831) Cleared Date: 22-APR-1996 BK950006 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:List #890F Extended Storage Plt Collection Set Cleared Date: 09-JUN-1995 BK950007 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:ESP White Cell Filter (No. 790F) Cleared Date: 28-JUN-1995 BK950033 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics PCS2 Cleared Date: 16-APR-1996 BK950034 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Double Product Collection (SDP-3) Cleared Date: 15-FEB-1996 BK950063 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 Trade Name:Double Unit Red Blood Cell Aphersis Set MCS #833 Cleared Date: 15-OCT-1996 BK960022 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:MCS+Double Unit RBC Apheresis Set- Dry(LN832) Cleared Date: 16-APR-1997 BK960023 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:MCS+Red Cell & Plasma Apheresis Set - Dry(LN822) Cleared Date: 16-APR-1997 BK960095 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:MCS+Apheresis System (LN8150) Cleared Date: 11-APR-1997 BK970029 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 Trade Name:LN994CF Cleared Date: 15-SEP-1998 BK970041 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 Trade Name:Citroflex Plalsticized PVC Extended Storage Platelet Bag Cleared Date: 07-JAN-1999 BK000002 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Model 215 Automated Glycerolization and Deglycerolization System Cleared Date: 04-MAY-2001 BK990033 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:MCS+ LN8150 Cleared Date: 20-JAN-2000 BK990044 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 Trade Name:Haemonetics LN832F Cleared Date: 09-APR-2001 BK010035 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:MCS+ Mobile Collection System Cleared Date: 20-DEC-2002 BK020001 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Plasma Pooling Bottle II Cleared Date: 29-MAR-2002 BK030031 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics Model 215 Automated Glycerolyzation / Deglycerolyzationand Cell Washing System Cleared Date: 10-SEP-2003 BK030062 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics Model 215 Automated Glycerolization/deglycerolization System Cleared Date: 10-DEC-2003 BK030084 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 Trade Name:Haemonetics 4mL Sampling System Cleared Date: 27-FEB-2004 BK040020 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 Trade Name:PCS2 Plasma Collection System Cleared Date: 02-JUN-2004 BK040041 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics MCS+8150 Apheresis System Cleared Date: 12-JUL-2004 BK040077 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics Model 215 Automated Glycerolization/Deglycerolization System Cleared Date: 21-DEC-2004 BK050006 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:ACP 215 Glycerolization/Deglycerolization System Cleared Date: 14-APR-2005 BK050047 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 Trade Name:Haemonetics MCS+ 8150 Apheresis System Cleared Date: 27-SEP-2005 BK060008 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics ACP 215 Glycerolization/Deglycerolization System Cleared Date: 23-MAY-2006 BK060023 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 Trade Name:Haemonetics MCS+ 8150 Apheresis System Cleared Date: 23-MAY-2006 BK060033 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 Trade Name:Cymbal Automated Blood Collection System Cleared Date: 28-FEB-2007 BK070019 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 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 02184-9114 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 BK090004 Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9144 Trade Name:MCS+8150 System - 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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 BK080070 Immucor, Inc. 3130 Gateway Drive Norcross, GA 30091-5625 Trade Name:Automated Blood Bank Analyzer Cleared Date: 05-FEB-2009 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. 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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. 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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 333 Milford Rd. 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 BK080060 MacoProductions S.A.S. 1733 Canton Lane Suite 103 Marietta, GA 30062-2679 Trade Name:Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells Cleared Date: 14-JAN-2009 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 BK090007 Medsep Corporation 1630 INDUSTRIAL PARK COVINA, CA 91722 Trade Name:Pall Acrodose PL System Cleared Date: 25-FEB-2009 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 BK080022 Olerup SSP AB Hasselstigen 1 SE 133 33 Saltsjobaden , Sweden Trade Name:Olerup SSP HLA Typing Kits Cleared Date: 20-FEB-2009 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 BK080014 Pall Life Sciences 25 Harbor Park Drive North Port Washington, NY 11050-4630 Trade Name:Pall eBDS Cleared Date: 13-FEB-2009 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 BK080069 SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 Trade Name:SoftDonor 4.5 - 4.5 Cleared Date: 16-JAN-2009 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 BK080073 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: 15-JAN-2009 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 BK080042 Sunquest Information Systems, Inc. 250 S. Williams Blvd. Tucson, AZ 85711 Trade Name:Sunquest Blood Bank Donor - 6.4 Cleared Date: 03-MAR-2009 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. 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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 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