Substantially Equivalent 510(k) Device Information

This list includes cleared 510(k) submissions for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status changes.

Complete List of Currently Cleared 510(k) Submissions.

Information is arranged in alphabetical order by the name of the applicant.



Applicant 510K Number Product Date
AbSorber AB
Sweden
BK070011 XM-ONE Transplantation Cross Match 7/29/2008
AcroMetrix Corp
Benicia, CA
BK060064 VeriSure Pro HBV DNA External Quality Control 2/8/2007
AcroMetrix Corp
Benicia, CA
BK050061 VeriSure Pro West Nile Virus (WNV) RNA External Quality Controls:
VeriSure Pro WNV RNA Negative External Quality Control
VeriSure Pro WNV RNA Positive External Quality Control
12/21/2005
Activated Cell Therapy, Inc
Mountain View, CA
BK960002 ACT Buoyant Density Solution 8/12/1996
Alba Bioscience
United Kingdom
BK080027 ALBAcheck - BGS Reagent Control for Anti-D 7/29/2008
Alba Bioscience
United Kingdom
BK070033 AlbaQ-Chek Simulated Whole Blood Controls 7/27/2007
Alpha Scientific Corp
Southeastern, PA
BK940054 SEG-SAFE 3/15/1995
Alpha Therapeutic Corp
City of Industry, CA
BK950044 Transfer Device 10/18/1995
American Blood Resources Association
Annapolis, MD
BK010012 National Donor Deferral Registry (NDDR) 1.0 8/30/2001
American Blood Resources Association
Annapolis, MD
BK960030 National Donor Deferral Registry 3/20/1997
American Red Cross Blood Services
Arlington, VA
BK20032 NGTL Automation System (NAS) 5.2.0 3/20/2003
Applied Biosystems / Celera Diagnostics
Alameda, CA 94502
BK030005 ViroSeq HIV-1 Genotyping System with the 3100 Genetic Analyzer 1/29/2003
Applied Science, Inc
Grass Valley, CA 95945
BK010031 Hemoflow Model 400 with Data Scanner 1/23/2002
Arlington Scientific, Inc
Springville, UT 84663
BK020031 ASI TPHA Test 1/30/2003
Arthrex Incorporated
Naples , FL 34108
BK070069 Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System 12/12/2008
Baxter Healthcare Corp
McGaw Park, IL
BK060061 ALYX Component Collection System: ALYX 2RBC-NLR Kit 2/9/2007
Baxter Healthcare Corp
McGaw Park, IL
BK050038 AMICUS Separator System 11/3/2005
Baxter Healthcare Corp
Round Lake, IL
BK040084 ALYX Component Collection System 3/15/2005
Baxter Healthcare Corp - Transfusion Therapies Division
Round Lake, IL
BK040059 Amicus Separator System 9/24/2004
Baxter Healthcare Corp
Round Lake, IL
BK020059 ALYX Component Collection System 1/23/2003
Baxter Healthcare Corp
Round Lake, IL
BK020056 ALYX System 12/20/2002
Baxter Healthcare Corp
Round Lake, IL
BK020008 LeukoConnect 12/16/2002
Baxter Healthcare Corp
Round Lake, IL
BK010033 Cygnet System 8/27/2002
Baxter Healthcare Corp
Round Lake, IL
BK000039 Amicus Separator, Concurrent Collection of Red Blood Cells 8/26/2002
Baxter Healthcare Corp
Round Lake, IL
BK000047 Amicus Separator, Mononuclear Cell Collection 7/31/2002
Baxter Healthcare Corp
Round Lake, IL
BK990009 Fenwal Amicus Separator Collection of Three Platelet Products 3/3/2000
Baxter Healthcare Corp
Round Lake, IL
BK980041 Sepacell Pre-Storage Leukocyte Set for Red Cells 7/16/1999
Baxter Healthcare Corp
Round Lake, IL
BK940009 Optipress Automated Blood Component Extractor 5/18/1994
Baxter Healthcare Corp
Round Lake, IL
BK920003 Fenwal Needle/Tube Sampling Protector and Needle Safety Cover 3/12/1992
BBI Diagnostics
West Bridgewater, MA 02379
BK060030 ACCURUN 804 Nucleic Acid Negative Quality Control (HIV, HCV, HBV, WNV) 8/18/2006
BBI Diagnostics
West Bridgewater, MA 02379
BK060022 ACCURUN 365 West Nile Virus RNA Positive Quality Control 6/12/2006
BD Biosciences
San Jose, CA 95131-1807
BK050073 BD HLA-B27 System 2/16/2006
BD Biosciences
San Jose, CA 95131-1807
BK050062 BD HLA-B27 kit 10/27/2005
BD Biosciences
San Jose, CA 95131-1807
BK030027 BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit 7/10/2003
Beckman Coulter, Inc
Miami, FL 33196-2500
BK040055 stemCXP System for the FC 500 with CXP Software 9/16/2004
Beckman Coulter, Inc
Miami, FL 33196-2500
BK040032 Stem-Kit Reagents 5/5/2004
Beckman Coulter, Inc
Miami, FL 33196-2500
BK020063 LeukoSure Enumeration Kit with Leuko-Trol RBC Control Cells and Leuko Trol Platelet Control Cells 2/3/2003
Beckman Coulter, Inc
Miami, FL 33196-2500
BK010044 stemONE System for EPICS XL/XL-MCL Flow Cytometry Systems 5/20/2002
Becton, Dickinson & Company
Franklin Lakes, NJ 07417-1885
BK060046 Bd.id Patient Identification System for Transfusion Management V7.00 2/13/2007
Becton, Dickinson & Company
Franklin Lakes, NJ 07417-1885
BK050036 BD Vacutainer SST II Advance Tubes; BD Vacutainer Plus K2EDTA Tubes; BD Vacutainer Plus Serum Tubes; BD Vacutainer SST Glass Tubes; BD Vacutainer SST Plus Tubes 2/24/2006
Becton, Dickinson & Company
Franklin Lakes, NJ 07417-1885
BK040030 BD Vacutainer Plus Plastic Serum Tubes with Clot Activator 5/5/2004
Becton Dickinson Vacutainer Systems
Franklin Lakes, NJ 07417
BK980011 VACUTAINER Brand PLUS (Plastic) Blood Collection Tube with EDTA Anticoagulant 6/7/1999
BioErgonomics, Inc
St. Paul, MN
BK000046 FluoroTrol Control Kits 4/2/2001
BioLife Plasma Services LP
Deerfield IL
BK060017 Donor Information System (DIS) 3.2 5/9/2006
BioLife Plasma Services LP
Deerfield IL
BK050029 Donor Information System (DIS) 3.1 7/7/2005
BioMerieux, Inc
Durham, NC 27712
BK050037 BacT/ALERT BPA Culture Bottle 12/27/2005
BioMerieux, Inc
Durham, NC 27712
BK050043 BacT/ALERT BPN Culture Bottle 12/27/2005
BioMerieux, Inc
Durham, NC 27712
BK030076 BacT/ALERT BPA Culture Bottles 3/8/2004
BioMerieux, Inc
Durham, NC 27712
BK030075 BacT/ALERT BPN Culture Bottles 3/8/2004
BioMerieux, Inc
Durham, NC 27712
BK030034 BacT/ALERT BPN Culture Bottle 7/18/2003
BioMerieux, Inc
Durham, NC 27712
BK020022 BacT/ALERT SN Culture Bottle 10/10/2002
BioMerieux, Inc
Durham, NC 27712
BK020023 BacT/ALERT SA Culture Bottle 10/10/2002
BioMerieux, Inc
Durham, NC 27712
BK000042 BacT/ALERT Culture Bottles 2/15/2002
Biomet,Inc.
Warsaw, IN
BK050016 GPS II Platelet Concentrate Separation Kit w/ Plasma Concentrator Accesory 7/20/2005
Biomet,Inc.
Warsaw, IN
BK040036 GPS II Platelet Concentrate Separation Kit 6/24/2004
Biometric Imaging, Inc
Mountain View, CA
BK970015 CEQer RBC Assay 9/18/1998
Biometric Imaging, Inc
Mountain View, CA
BK970016 CEQer PRP Assay 9/18/1998
Biometric Imaging, Inc
Mountain View, CA
BK970018 STELLer CD34 Assay 8/18/1998
Biosafe SA
Alexandria, VA
BK060036 Sepax Cell Separation System and single use kits 1/3/2007
Biotest AG
Germany
BK060066 TANGO Automated Blood Bank Analyzer System, Version 3.0 Service Pack 4 1/17/2007
Biotest Medical Diagnostics GmbH
Germany
BK080013 Alsever’s 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
7/23/2008
Biotest Medical Diagnostics GmbH
Germany
BK080012 Seraclone Control ABO+Rh; Coombscell-E; MLB2 7/23/2008
Biotest Diagnostics Corp
Denville, NJ
BK960061 Biotest DQB-ELPHA 8/4/1997
Biotest Diagnostics Corp
Denville, NJ
BK960086 Biotest High Resolution Supplementary Kit 7/3/1997
Blackhawk BioSystems, Inc
San Ramon CA
BK060052 AmpliTrol III 11/7/2006
Blood Bank Computer Systems, Inc
Auburn, WA
BK040087 BBCS Lab Interface Application (BBCS Lab) 5.0L 2/15/2005
Blood Bank Computer Systems, Inc
Auburn, WA
BK040056 Blood Bank Control System (BBCS) 5.0 10/22/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK040016 ACCURUN 305 HCV RNA Positive Quality Control 12/17/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK040067 ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV) 11/19/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK040064 ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150 10/29/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK040006 ACCURUN 315 HIV-1 RNA Positive Control 10/12/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK990032 Accurun 106 HIV-1 Antigen 1/20/2000
Care Fusion, Inc.
McLean, VA
BK040002 wBlood Care 1.0 11/10/2004
CaridianBCT, Inc.
Lakewood , CO
BK080043 Atreus Whole Blood Processing System 9/29/2008
CaridianBCT, Inc.
Lakewood , CO
BK080035 Trima Accel Automated Blood Component Collection System, COBE Spectra Apheresis System 8/29/2008
Cascade Medical Enterprises, LLC
Wayne, NJ
BK020051 Cascade Medical Fibrinet, Autologous Platelet System 12/20/2002
Celera Diagnostics
Alameda, CA
BK030033 ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer 6/11/2003
Celera Diagnostics/Applied Biosystems, Inc
Alameda, CA
BK010024 ViroSeq HIV-1 Genotyping System 12/10/2002
Cerner Corporation
Kansas City, MO
BK060037 Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.3 5/24/2007
Cerner Corporation
Kansas City, MO
BK030028 Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 8/19/2003
Charter Medical, Ltd
Winston-Salem NC
BK050021 Charter Medical Transfer Set 7/22/2005
Charter Medical, Ltd
Winston-Salem NC
BK060042 Cell Freeze Liquid Nitrogen Freezing Container 10/3/2008
Chiron Corporation
Emeryville, CA
BK060005 Chiron Procleix NAT Tracker 3.0 3/1/2006
Chiron Corporation
Emeryville, CA
BK050004 Procleix Optiva RAS 4/8/2005
COBE Cardiovascular, Inc
Arvada, CO
BK050033 COBE Angel Whole Blood Separation System 8/22/2005
COBE BCT
Lakewood, CO
BK990025 COBE Trima 4/7/2000
COBE BCT
Lakewood, CO
BK970005 Focussed System 10/13/1998
Community Bio-Resources, Inc
Hoover, AL
BK970007 Donor Information System, Version 1.0 4/9/1997
Cytomedix, Inc
Rockville, MD
BK060007 AutoloGel System 9/20/2007
CytoTherm
Trenton, NJ
BK080019 CytoTherm Plasma Thawing System 7/16/2008
CytoTherm LP
Trenton, NJ
BK060027 CytoTherm Plasma Thawing System 8/1/2006
Data Innovations, Inc
South Burlington, VT
BK060053 Instrument Manager 8.05.01.10 1/5/2007
Data Innovations, Inc..
South Burlington, VT
BK020057 imExpress 7.2.5 7/29/2003
DENCO, Inc
Wilmington, DE
BK000022 Total Containment Device 4/18/2000
DENCO, Inc
Wilmington, DE
BK990041 Total Containment Device TCD 12/21/1999
Department of Veterans Affairs
Hines IL
BK060043 VistA Blood Establishment Computer Software (VBECS) 1.0 10/19/2006
Digi-Trax Corp
Buffalo Grove, IL
BK010049 Donor-ID 2.2 4/26/2002
Digi-Trax Corp
Buffalo Grove, IL
BK000020 Digi-Trax Donor-ID 2.0 4/20/2000
Digi-Trax Corp
Buffalo Grove, IL
BK970013 DONOR-ID, version 1.0 2/27/1998
Dynal Biotech Ltd
Croft Busines Park, UK
BK050012 Dynal RELI SSO HLA-DRB1 Typing Kit
For use as a manual assay or with the AutoRELI 48 instrument
5/18/2005
Dynal Biotech Ltd
Bromborough, Wirral, UK
BK030056 Dynal Reli SSO HLA-A Typing Kit 1/29/2004
Dynal Biotech Ltd
Bromborough, Wirral, UK
BK030057 Dynal Reli SSO HLA-B Typing Kit 1/29/2004
Dynal Biotech Ltd
Bromborough, Wirral, UK
BK030058 Dynal Reli SSO HLA-Cw Typing Kit 1/29/2004
Dynal Biotech Ltd
Bromborough, Wirral, UK
BK030059 Dynal Reli SSO HLA-DQB1 Typing Kit 1/29/2004
Dynal Biotech Ltd
Bromborough, Wirral, UK
BK030060 Dynal Reli SSO HLA-DRB Typing System 1/29/2004
Dynamic Healthcare Technologies, Inc
Maitland, FL
BK960041 Transfusion Service Manager, Version 4.1.6 12/16/1997
Fenwal Inc.
Three Corporate Drive
Lake Zurich , IL 60047
BK080048 AMICUS® Separator: Software 3.1 with EDI Export 10/2/2008
Fenwal Inc.
Three Corporate Drive
Lake Zurich , IL 60047
BK080018 Amicus Separator System 8/26/2008
Fenwal Inc.
Three Corporate Drive
Lake Zurich , IL 60047
BK080033 PLASMALINK 8/22/2008
Fenwal Inc.
Three Corporate Drive
Lake Zurich , IL 60047
BK080024 ALYX Component Collection System 6/24/2008
Fifth Dimension Information Systems
Edmonton, Alberta T5J 2Z2
CANADA
BK050060 E-Interview (eQue) 1.0.0 5/24/2006
Fifth Dimension Information Systems
Edmonton, Alberta T5J 2Z2
CANADA
BK040040 LOGIC 2.0 10/6/2004
Fifth Dimension Information Systems
Edmonton, Alberta T5J 2Z2
BK020058 LOGIC 1.0 2/3/2003
Fresenius Hemocare Inc
Lexington, MA 02420
BK040076 Compodock 12/17/2004
Fresenius Hemocare Inc
Lexington, MA 02420
BK040005 Fresenius Compoguard & Donationmaster NT 3/26/2004
Fresenius Hemocare Inc
Redmond, WA 98052
BK030022 Fresenius Compomat G4 & Compomaster NT 7/11/2003
Fujirebio Diagnostics, Inc
Malvern, PA
BK070030 Olympus PK CMV-PA Test System and Controls for the Olympus PK7300 Automated Blood Bank Analyzer 9/20/2007
Fujirebio Diagnostics, Inc
Malvern, PA
BK060062 Olympus PK TP Reagent System 6/25/2007
Fujirebio Diagnostics, Inc
Malvern, PA
BK030007 Olympus PK TP System 2/21/2003
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK080010 The Atreus Whole Blood Processing System 6/27/2008
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK070066 Vista Information System, Version 3.0 with Medical Review Module 12/13/2007
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK040086 COBE Spectra Apheresis System & Trima Automated Blood Component Collection System 3/15/2005
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK040069 Trima Automated Blood Component Collection System - Blood Component Sampling Accessary 10/28/2004
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK010037 Platelet collection sets for the COBE Spectra Apheresis System and the Trima Automated Blood Component Collection System 9/24/2003
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK030021 Vista Information System 2.1 5/1/2003
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK020041 COBE Spectra Apheresis System/Blood component disposable collection sets for apheresis 4/23/2003
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK010050 Trima Automated Blood Collection System 9/18/2002
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK010046 Trima Automated Blood Collection System (Single Stage) 9/18/2002
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK020015 Vista Information System, Independent Solution 7/15/2002
Gambro BCT, Inc
Lakewood, CO 80215-4498
BK010006 Trima Automated Blood Component Collection System 2/27/2002
Gaymar Industries, Inc
Washington, DC 20006-4706
BK060050 Medi-Temp III, Model FW600 Blood/Fluid Warmer 11/7/2006
GE Medical Information Technologies
Barrington, IL
BK050018 Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 6/13/2005
Genetic Testing Institute
Brookfield, WI
BK960059 PAKAUTO Platelet Antibody Screening Kit 10/22/1998
Gen-Probe, Inc
San Diego CA
BK060021 Procleix TIGRIS System for use with the Procleix WNV Assay 2/20/2007
Greiner Bio-One North America, Inc.
Monroe, NC 28110
BK050026 Greiner Vacuette No Additive Tubes 7/7/2005
Greiner Bio-One North America, Inc.
Monroe, NC 28110
BK050028 Greiner Vacuette Clot Activator Tube 7/7/2005
Greiner Bio-One GmbH
Westmont, IL 60659
BK030032 Greiner Vacuette EDTA K2 Evacuated Blood Collection Tube 7/18/2003
Greiner Bio-One GmbH
Westmont, IL 60659
BK030001 Greiner Vacuette EDTA K3 Tube 2/26/2003
GTI, INC
Waukesha, WI 53186
BK070045 Donor Screen HLA Class I and Class II 7/30/2008
GTI, INC
Waukesha, WI 53186
BK060038 MICROAMS 7/28/2006
GTI, INC
Waukesha, WI 53186
BK050054 GranType 3/2/2006
GTI, INC
Waukesha, WI 53186
BK050040 ThromboType (HPA 1-6, 15) and ThromboType 1 (HPA 1) 1/20/2006
GTI, INC
Waukesha, WI 53186
BK040034 Lifecodes LifeScreen: A Luminex 100 Screening Assay for the Detection of IgG Antibodies to HLA Class I and Class II Molecules of Human Origin 7/16/2004
GTI, INC
Waukesha, WI 53186
BK040035 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
7/16/2004
GTI, INC
Waukesha, WI 53186
BK040019 Antibody Monitoring System Class 1 and Class II (AMS1 and AMS1+2) 7/6/2004
Haemonetics Corp
Braintree, MA 02184
BK080038 MCS+ 9000 System 9/4/2008
Haemonetics Corp
Braintree, MA 02184
BK080025 Cymbal Automated Blood Collection System 8/15/2008
Haemonetics Corp
Braintree, MA 02184
BK080001 PCS2 Plasma Collection System_Revision K software 5/28/2008
Haemonetics Corp
Braintree, MA 02184
BK060008 Haemonetics ACP 215 Glycerolization/Deglycerolization System 5/23/2006
Haemonetics Corp
Braintree, MA 02184
BK050047 MCS+9000, SDP revision E software, 994CF-CPP series disposable sets 11/21/2005
Haemonetics Corp
Braintree, MA 02184
BK050006 ACP 215 Glycerolization/Deglycerolization System 4/14/2005
Haemonetics Corp
Braintree, MA 02184
BK040077 Haemonetics Model 215 Automated Glycerolization/Deglycerolization System 12/21/2004
Haemonetics Corp
Braintree, MA 02184
BK040041 Haemonetics MCS+8150 Apheresis System 07/12/2004
Haemonetics Corp
Braintree, MA 02184
BK040025 PCS2 Plasma Collection System 06/02/2004
Haemonetics Corp
Braintree, MA 02184
BK040020 Haemonetics LN994CF-BA Extended Storage Platelet and Plasma Apheresis Set with Leukocyte Reduction Filter, and 4 mL Sampling System 03/29/2004
Haemonetics Corp
Braintree, MA 02184
BK040001 Haemonetics 4mL Sampling System 02/27/2004
Haemonetics Corp
Braintree, MA 02184
BK030062 Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation System 12/10/2003
Haemonetics Corp
Braintree, MA 02184
BK030031 Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation and Cell Washing System 9/10/2003
Haemonetics Corp
Braintree, MA 02184
BK010035 MCS+ Mobile Collection System 12/20/2002
Haemonetics Corp
Braintree, MA 02184
BK020001 Plasma Pooling Bottle II 3/29/2002
Haemonetics Corp
Braintree, MA 02184
BK000002 Model 215 Automated Glycerlization and Deglycerolization System 5/4/2001
Haemonetics Corp
Braintree, MA 02184
BK000048 Haemonetics LN832F 4/9/2001
Haemonetics Corp
Braintree, MA 02184
BK990033 MCS+ LN8150 Red Cell Apheresis Instrument 1/20/2000
Harvest Technologies
Norwell, MA
BK000037 Harvest PRP Separation System 2/5/2001
Healthcare-ID
Buffalo Grove, IL
BK060058 Donor-ID 3.0 2/8/2007
Healthcare-ID
Buffalo Grove, IL
BK030049 Donor-ID 10/31/2003
Healthcare Management Systems, Inc
Nashville TN 37203
BK050001 Monitor Blood Administration Module Release 24.0 9/28/2005
Helmer Labs, Inc
Noblesville, IN 46060
BK020029 UltraCW (with Software version 3.13) 10/04/2002
Hemasure, Inc
Marlborough, MA
BK980014 HemaSure r|LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells 5/27/1999

Hemerus Medical, LLC
Saint Paul , MN 55110

BK080031 HEMERUS LEUKOSEP ® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells 9/11/2008
HemoCue AB
Sweden
BK060048 HemoCue Hb 301 System 10/5/2006
HemoCue, Inc
Potomac, MD
BK030067 HemoCue Donor Hb Checker System 12/19/2003
HemoCue, Inc
Potomac, MD
BK030020 Donor Hemoglobin Checker System 4/17/2003
HemoCue, Inc
Potomac, MD
BK000043 HemoCue Low Hemoglobin Analyzing System 4/9/2001
Hemosystem, S.A.
Richmond, VA
BK040031 Scansytem Bacterial Detection Device 9/23/2004
Immucor, Inc
Norcross, GA
BK070054 Galileo Automated Blood Bank System - Add the Reverse ABO Group Assay 11/30/2007
Immucor, Inc
Norcross, GA
BK070040 Galileo Automated Blood Bank System with assays to perform red blood cell phenotying 9/28/2007
Immucor, Inc
Norcross, GA
BK070016 Galileo Echo Automated Blood Bank System 6/14/2007
Immucor, Inc
Norcross, GA
BK070015 WB corQC 6/14/2007
Immucor, Inc
Norcross, GA
BK070014 DAT Positive Control Cell 6/14/2007
Immucor, Inc
Norcross, GA
BK070013 Monoclonal Control 6/14/2007
Immucor, Inc
Norcross, GA
BK060009 Galileo Automated Blood Bank System with Capture-S Syphilis Screening 4/11/2006
Immucor, Inc
Norcross, GA
BK050050 Galileo Automated Blood Bank System Capture-CMV 11/14/2005
Immucor, Inc
Norcross, GA
BK040057 Check cell (Weak) 10/6/2004
Immucor, Inc
Norcross, GA
BK040024 Capture-R Select Solid Phase System 4/28/2004
Immucor, Inc
Norcross, GA
BK040013 Galileo version 1.3.6 SP4/DMS version 1.26 4/23/2004
Immucor, Inc
Norcross, GA
BK000024 ABS2000, Version 2 software (2.05.00A and 2.0500B) 7/3/2001
Immucor, Inc
Norcross, GA
BK960019 ABS2000 6/30/1998
Indico, Inc
Edmonton, ALBERTA T6G 2E1 CANADA
BK000008 RadTag X-ray 3/1/2000
Information Data Management, Inc
Rosemont, IL 60018
BK070031 IDM Symphony System 2.0 12/13/2007
Information Data Management, Inc
Rosemont, IL 60018
BK050014 IDM Prelude System, Version 1.1 7/18/2005
Information Data Management, Inc
Rosemont, IL 60018
BK020038 Surround System, Version 3.2 10/8/2002
Information Data Management, Inc
Rosemont, IL 60018
BK010028 IDM Surround System 3.0 8/30/2001
Information Data Management, Inc
Rosemont, IL 60018
BK000016 Information Data Management Surround System 2.0 4/7/2000
Information Data Management, Inc
Rosemont, IL 60018
BK950037 Components & Distribution Information System 8/26/1996
Information Data Management, Inc
Rosemont, IL 60018
BK950045 Donor Management Information Systems, vers.1.2 8/26/1996
Infra-Med Technologies, Inc
Dallas, TX
BK990018 Hot Shot Fluid Warmer 10/13/1999

IntelliDOT Corporation
San Diego, CA

BK080006 IntelliDOT Blood Product Administration 6/13/2008
Invitrogen Corp
Brown Deer WI
BK070038 AllSet Gold SSP 9/26/2007
ITL Corporation, Ltd
Fyshwick, Canberra, Australia
BK980008 Bloodpack Needle Protector (BNP) 4/7/1998
Korchek Technologies, LLC
Trumbull CT 06611
BK040053 CareChek Patient Identification System, CareChek, Version 1.0 8/12/2005
Kowa Company, Ltd
Rockville, MD 20852
BK030037 LD-2000 Leukocyte Counter 6/14/2004
Level 1 Technologies, Inc
Rockland, MA 02370
BK020043 Level 1 Fluid warming System 6/16/2003
LifeSouth Community Blood Centers Inc
Gainesville FL 32607
BK080017 Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 8/5/2008
Ljungber & Kogel
Deerfield, IL
BK990013 Biomixer 330 & Biomixer 323 7/7/1999
MacoProductions S.A.S.
c/o Hoppe Regulatory Consultants
Decatur, GA
BK050041 Leucolab LCG2 Leukoreduction System for Red Blood Cells 10/12/2005
Maco Pharma c/o Hoppe Regulatory Consultants
Decatur, GA
BK030008 Leucolab LCG2 Leukoreduction System for Red Blood Cells 5/2/2003
MAK-System
France
BK070062 PROGESA 4.4h 10/26/2007
MAK-System
Paris France
BK060035 Patient Health Software 1.0 5/9/2007
MEDITECH Medical Information Technology, Inc.
MEDITECH Circle
Westwood MA 02090
BK080037 MEDITECH Client Server Blood Bank module v5.6 10/30/2008
MEDITECH Medical Information Technology, Inc
Westwood, MA
BK980046 Magic Client Server, Version 5.1 2/8/2000
Mediware Information Systems, Inc.
Oak Brook, IL 60523
BK080049 HCLL Transfusion, v3.0 10/22/2008
Mediware Information Systems, Inc
Irving, TX 75038
BK060019 LifeTrak / Donor 3.01 6/21/2006
Mediware Information Systems, Inc
Irving, TX 75038
BK050011 HCLL Donor 1.0 5/10/2005
Mediware Information Systems, Inc
Irving, TX 75038
BK040047 Instrument Interface Engine 1.0 7/16/2004
Mediware Information Systems, Inc
Irving, TX 75038
BK030078 HCLL 2.6 4/8/2004
Mediware Information Systems, Inc
Dallas, TX 75235
BK010052 LifeTrak Lab 2.03 6/17/2002
Mediware Information Systems, Inc
Dallas, TX 75235
BK020046 Hemocare LifeLine Version, 1.0 2/14/2003
Medsep Corp
Pepper Pike, OH
BK080003 Pall® AcrodoseT PLus System, Platelet Pool and Store Set with in-Line Leukocyte Reduction Filter 4/18/2008
Medsep Corp
Covina, CA
BK070004 Pall eBDS 6/26/2007
Medsep Corp
Pepper Pike, OH
BK050074 Pall Acrodose PL System 1/26/2006
Medsep Corp
Covina, CA
BK050034 Pall Acrodose PL System, Platelet Pool and Store Set with eBDS 9/28/2005
Medsep Corp
Covina, CA
BK020014 Pall Bacterial Detection System (BDS) 10/22/2002
Medsep Corp
Covina, CA
BK000032 Modified Plasma Bag 9/27/2000
Medsep Corp
Covina, CA
BK970040 Medsep Plasma Bag (EVA Plastic) 1/23/1998
Medserv, Inc
Mount Kisco, NY 10549
BK010032 Plasmapheresis Data System III 1.0 2/5/2002
Medtronic Sofamor Danek
Memphis, TN 38132
BK040068 Magellan Autologous Platelet Separator System 11/9/2004
Medtronic Sofamor Danek
Memphis, TN 38132
BK030040 Magellan Autologous Platelet Separation System 9/3/2003
Micro Typing Systems Inc.
Pompano Beach, FL
BK030023 Ortho ProVue, Software Version: 2.10 05/30/2003
Microwave Medical System
Acton, MA
BK970045 ThermoStat 900 Blood & IV Fluid Adm. Set 03/6/1998
Microwave Medical System
Acton, MA
BK970044 ThermoStat 900 1/23/1998
Mississippi Blood Services, Inc.
Jackson, MS
BK030065 WebLab Online Laboratory System 2.0 12/22/2003
Misys Healthcare Systems
Tucson, AZ 85711
BK040065 Misys Laboratory Blood Bank and Blood Donor 6.0.1 10/22/2004
Mosum Technology India PVT LTD
Great Neck NY
BK060014 PowerBANK Enterprise Edition version 1.0 3/30/2007
Neoteric Technology Ltd
Vancouver British Columbia, Canada
BK060041 BloodTrack 4.1 10/17/2006
Neoteric Technology Ltd
Vancouver British Columbia, Canada
BK050032 BloodTrack SafeTx Version 2.0 8/16/2005
Olympus America Inc
Irving TX 75063-3104
BK050076 TANGO Automated Blood Bank Analyzer System (HW Version 02/SW Version 3.0) 12/16/2005
Olympus America Inc
Irving, TX 75063-3104
BK040070 Tango Automated Blood Bank Analyzer System 3/22/2005
One Lambda, Inc
Canoga Park, CA
BK050070 HLA Visual Software version 1.0 1/30/2006
One Lambda, Inc
Canoga Park, CA
BK050071 HLATools Software, Version 1.0 1/30/2006
One Lambda, Inc
Canoga Park, CA
BK050008 LABScreen Software 7/8/2005
One Lambda, Inc
Canoga Park, CA
BK040049 LabType Visual 8/9/2004
One Lambda, Inc
Canoga Park, CA
BK030069 LABScreen Products for use with LABScan 100 flow analyzer 12/31/2003
One Lambda, Inc
Canoga Park, CA
BK980015 FlowPRA 7/23/1999
One Lambda, Inc
Canoga Park, CA
BK960062 Micro SSP HLA Class II DNA typing Kit 2/11/1998
OriGen BioMedical
Austin, TX 78758
BK030036 OriGen Cryostore Freezing Bags 10/1/2003
Ortho-Clinical Diagnostics, Inc
Rochester, NY
BK070028 VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls 4/10/2008
Ortho-Clinical Diagnostics, Inc
Raritan, NJ 08869-0606
BK990030 Ortho Lab with Ortho Lab IC (Instrument Concentrator) 4/3/2000
Pel-Freez Clinical Systems, LLC
Brown Deer, WI 53223
BK000019 UniTray SSP HLA Typing Kits 1/29/2001
Pel-Freez Clinical Systems, LLC
Brown Deer, WI 53223
BK030003 UniMatch Plus 2/25/2003
Perfusion Partners & Associates, Inc
Fort Myers FL 33912
BK050055 GenesisCS Component Concentrating System 10/13/2006
Prescott Ideas LLC
Tucson AZ 85710
BK060056 Antibody Check 4.1 4/23/2007
Psyche Systems Corp
Wellesley, MA 02481
BK010017 System Blood Bank (SBB) Software 3.0 9/4/2001
R & D Systems, Inc
Minneapolis, MN
BK040063 R & D Plasma Hemoglobin Hematology Control 9/17/2004
R & D Systems, Inc
Minneapolis, MN
BK040012 R&D Donor Checker Hematology Control 3/5/2004
R & D Systems, Inc
Minneapolis, MN
BK000035 R & D Leuko-Reduced RBC Control 12/13/2000
R & D Systems, Inc
Minneapolis, MN
BK000036 R & D Leuko-Reduced Plt Control 12/13/2000
Rubin & Poor, Inc
Maplewood, NJ 07040
BK030073 Configurable Manual Batch Entry, Version 1.1A 1/14/2004
Rubin & Poor, Inc
Maplewood, NJ 07040
BK010025 Chiron Procleix NAT Tracker 1.0E 1/3/2002
Rubin & Poor, Inc
Maplewood, NJ 07040
BK000030 Configurable Laboratory Result Manager (CLRM) 1.0E 11/23/2001
Rubin & Poor, Inc
Maplewood, NJ 07040
BK080028 Pool Results Manager Version 1.0C, Module for Roche NAT Testing Version 2.0A 9/3/2008
Rubin & Poor, Inc
Maplewood, NJ 07040
BK990008 Rubin & Poor Configurable Manual Blot System 1.0C 10/29/1999
Sanguin International Limited
Hambden, CT
BK980003 Aurora / Fenestra 1.0 9/29/1999
Sarstedt, Inc
Newton, NC
BK070029 S-Monovette ACD-A Blood Collection System 9/21/2007
Sarstedt, Inc
Newton, NC 28658
BK030006 Transwaag Disk 01 2/27/2003
Sarstedt, Inc
Newton, NC 28658
BK010045 Sahara Blood & Plasma Warming Device 12/21/2001
Sarstedt, Inc
Newton, NC 28658
BK010042 Transwaag KL 12/12/2001
SCC Soft Computer
Clearwater FL
BK080020 SoftBank II v23.2 8/12/2008
SCIMEDX Corp
Denville, NJ
BK960070 Olympus PK-TP System Control Set 6/19/1997
Separation Technology, Inc
Altamonte Springs FL
BK050056 UltraChek Reference Controls - Product Code GLK
UltraCrit Hematocrit Measurement Device - Product Code GKF
12/12/2005
SG SCientific
Gainesville, FL
BK950057 The Saber, (Segment Piercing Device) 11/13/1995
Shared Medical Systems
Malvern, PA
BK960036 SMS Blood Bank Transfusion System 12/12/1997
Sienna Partners
Baldwin, MD
BK040066 Greiner VACUETTE No Additive Evacuated Blood Collection Tubes and Serum Clot Activator Blood Collection Tubes 9/10/2004
Sienna Partners
Baldwin, MD
BK040018 VACUETTE EDTA K2 tube; VACUETTE EDTA K3 tube 7/28/2004
Smith & Nephew, Inc
Memphis, TN
BK060004 Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System 5/2/2006
Soft Computer Consultants, Inc
Palm Harbor, FL
BK040048 SoftBank II v23.1 with Database Management System Interface (DMSI) 8/23/2004
Soft Computer Consultants, Inc
Palm Harbor, FL
BK040028 SoftBank II version 23 with SoftScape 5/7/2004
Soft Computer Consultants, Inc
Palm Harbor, FL
BK030018 SoftBank II 23 4/17/2003
Soft Computer Consultants, Inc
Palm Harbor, FL
BK020006 SoftDonor 4.1 2/27/2003
Soft Computer Consultants, Inc
Palm Harbor, FL
BK020021 SoftBank II 22 9/11/2002
Stemco Biomedical, Inc
Durham, NC
BK040075 Aldecount Progenitor Cell Enumeration Kit 1/6/2005
Stemco Biomedical, Inc
Durham, NC
BK030064 Aldecount Progenitor Cell Enumeration Kit 12/31/2003
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK060032 LifeTec Elite 1.0 8/21/2006
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK040026 LifeTec Donor Verification and Collection System (DOVAC) 1.00 10/21/2004
Talisman Ltd
Vienna, VA
BK070020 Quality Donor System v2.1 7/16/2007
Talisman Ltd
Vienna, VA
BK060031 Talisman Phlebotomy System, Release 1.0 7/27/2006
Talisman Ltd
Vienna, VA
BK040062 Quality Donor System 2004 2.0 10/18/2004
Tepnel Lifecodes Corporation
Stamford CT 06902
BK050003 LIFECODES HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB Typing Kits for use with Luminex 100 7/18/2005
Terumo Medical Corp
Elkton, MD
BK040082 TSCD-II Terumo Sterile Tubing Welder 4/5/2005
Terumo Medical Corp
Elkton, MD
BK020033 Imugard III-PL Leukocyte reduction filter 5/22/2003
Terumo Medical Corp
Elkton, MD
BK970008 Terumo Sterile Tubing Welder SC-201A (TSCD) 5/28/1998
Terumo Medical Corp
Elkton, MD
BK970011 Terumo Phlebotomy Needle Cap Holder 6/19/1997
Texas BioGene, Inc
Richardson TX
BK060060 Morgan HLA SSP ABDR Typing Kit 3/22/2007
Thermogenesis
Rancho Cordova, CA
BK960072 CryoSeal System 2/12/1999
Thermogenesis
Rancho Cordova, CA
BK070006 AXP AutoXpress Platform 10/5/2007
The Surgical Company International
Netherlands
BK070055 Fluido Accessories: Fluido Air Guard, Fluido Compressor, Fluido IV-Pole and Fluido Pressure Chamber 1/15/2008
The Surgical Company International
The Netherlands
BK050058 Fluido Blood and Fluid Warmer System 5/5/2006
Utah Medical Products, Inc
Midvale, UT
BK970026 Umbilicup 1/28/1998
VEEGEE Scientific
Kirkland, WA 98034
BK010043 Atago SP-D2 Refractometer 1/2/2002
Verax Biomedical Inc
Worcester, MA
BK070044 Platelet PGD Test System 9/17/2007
Visible Genetics, Inc
Toronto, Ontario
BK000038 TRUEGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System 9/26/2001
Wyndgate Technologies
El Dorado Hills CA
BK070064 ElDorado Donor 1.0.0 2/13/2008
Wyndgate Technologies
El Dorado Hills CA
BK070010 ElDorado Donor Doc 1.0.0 5/23/2007
Wyndgate Technologies
Rancho Cordova, CA
BK980023 SafeTrace TX, version 1.0 1/29/1999
ZLB Behring AG
Bern, Switzerland
BK050078 System for Plasma Identification (SPI) 2.0.0 12/22/2005
ZLB Bioplasma AG
Bern, Switzerland
BK020020 System for Plasma Identification (SPI) 1.0 10/30/2002
 
Updated: December 19, 2008