Vaccines, Blood & Biologics

Cleared 510(k) Submissions with Supporting Documents

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 change.

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

Substantially Equivalent 510(k) Device Information

Biologics Products & Establishments


  A   |  B  |   C  |   D  |   E - F  |   G  |   H  |   I  |  J - K - L  |  M  |  N  |  O  |   P  |  Q - R  |  S  |   T  |   U  |   V  |  W  |  X - Y - Z 

Applicant 510K Number Product Date
A
Abbott Laboratories
Abbott Park, IL
BK950048 Abbott Apheresis Tracking System (AARTS) Version 1.0 06/24/1998
Abbott Laboratories
Abbott Park, IL
BK950052 Abbott DMS II Version 1.5 08/12/1998
Abbott Laboratories
Abbott Park, IL
BK950032 Abbott DMS Version 3.0.2 08/18/1998
Abbott Laboratories
Abbott Park, IL
BK010036 Abbott Prism Retest 07/17/2002
AbSorber AB
SWEDEN
BK070011 XM-ONE Transplantation Cross Match 07/29/2008
AcroMetrix Corp
Benicia, CA
BK060064 VeriSure Pro HBV DNA External Quality Control 02/08/2007
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 08/12/1996
ADAC HealthCare Information System
Houston, TX
BK960027 LabCare Blood Bank II Version 13.3 08/12/1998
Alba Bioscience Limited
United Kingdom
BK150246 ORTHO™ Sera Papain 10/20/2015
ALBA Bioscience Limited
United Kingdom
BK150217 ALBAsure® QC Kit 03/31/2015
Alba Bioscience Limited
United Kingdom
BK140208 ALBAcyte® C3 Coated Red Blood Cells 03/04/2015
Alba Bioscience Ltd
United Kingdom
BK140144 ALBAzyme™ Papain Solution kit 09/17/2014
Alba Bioscience
United Kingdom
BK100005 ALBAcyte® IgG Sensitized Red Blood Cells 08/26/2010
Alba Bioscience
United Kingdom
BK090030 ALBAcheck® - BGS Simulated Whole Blood Controls 06/14/2010
Alba Bioscience
United Kingdom
BK080051 FETALSCREEN™ II 04/08/2009
Alba Bioscience
United Kingdom
BK080027 ALBAcheck - BGS Reagent Control for Anti-D 07/29/2008
Alba Bioscience
United Kingdom
BK070033 AlbaQ-Chek Simulated Whole Blood Controls 07/27/2007
Alpha Scientific Corp
Southeastern, PA
BK940054 SEG-SAFE 03/15/1995
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 08/30/2001
American Blood Resources Association
Annapolis, MD
BK960030 National Donor Deferral Registry 03/20/1997
American National Red Cross Gaithersburg, MD BK120042 DailyChek QC Kit 10/6/2012
American Red Cross
Washington, DC
BK960040 National Biomedical Computer System, Version 1.1 02/28/1997
American Red Cross Blood Services
Arlington, VA
BK020032 NGTL Automation System (NAS) 5.2.0 03/20/2003
American Red Cross
Gaithersburg, MD
BK090021 American Red Cross Control Cells 06/24/2009
Applied Biosystems / Celera Diagnostics
Alameda, CA
BK030005 ViroSeq HIV-1 Genotyping System with the 3100 Genetic Analyzer 01/29/2003
Applied Science, Inc
Grass Valley, CA
BK010031 Hemoflow Model 400 with Data Scanner 01/23/2002
Arlington Scientific, Inc
Springville, UT
BK140192 ASiManager-AT 02/19/2015
Arlington Scientific, Inc
Springville, UT
BK020031 ASI TPHA Test 01/30/2003
Arthrex Incorporated
Naples, FL
BK070069 Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System 12/12/2008
Back to Alphabetical Index
B
Barkey GmbH & Co. KG
Germany
BK100063 plasmatherm 11/17/2011
Baxter Healthcare Corp
Glendale, CA
BK020002 Serology SQL LIMS 1.0 08/07/2002
Baxter Healthcare Corp
McGaw Park, IL
BK060061 ALYX Component Collection System: ALYX 2RBC-NLR Kit 02/09/2007
Baxter Healthcare Corp
McGaw Park, IL
BK050038 AMICUS Separator System 11/03/2005
Baxter Healthcare Corp
Round Lake, IL
BK040084 ALYX Component Collection System 03/15/2005
Baxter Healthcare Corp - Transfusion Therapies Division
Round Lake, IL
BK040059 Amicus Separator System 09/24/2004
Baxter Healthcare Corp
Round Lake, IL
BK020059 ALYX Component Collection System 01/23/2003
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 08/27/2002
Baxter Healthcare Corp
Round Lake, IL
BK000039 Amicus Separator, Concurrent Collection of Red Blood Cells 08/26/2002
Baxter Healthcare Corp
Round Lake, IL
BK000047 Amicus Separator, Mononuclear Cell Collection 07/31/2002
Baxter Healthcare Corp
Round Lake, IL
BK990009 Fenwal Amicus Separator Collection of Three Platelet Products 03/03/2000
Baxter Healthcare Corp
Round Lake, IL
BK980041 Sepacell Pre-Storage Leukocyte Set for Red Cells 07/16/1999
Baxter Healthcare Corp
Round Lake, IL
BK940009 Optipress Automated Blood Component Extractor 05/18/1994
Baxter Healthcare Corp
Round Lake, IL
BK920003 Fenwal Needle/Tube Sampling Protector and Needle Safety Cover 03/12/1992
Bayer Corp
Berkeley, CA
BK960051 Plasma Procurement Information System Version 2.0 08/07/1998
Bayer Corp
Berkeley, CA
BK990024 Plasma Procurement Information System (PPIS), version 3.0 11/03/1999
Bayer Corp
Berkeley, CA
BK990037 Plasma Procurement Information System (PPIS), version 4.0 11/17/1999
BBI Diagnostics
West Bridgewater, MA
BK060030 ACCURUN 804 Nucleic Acid Negative Quality Control (HIV, HCV, HBV, WNV) 08/18/2006
BBI Diagnostics
West Bridgewater, MA
BK060022 ACCURUN 365 West Nile Virus RNA Positive Quality Control 06/12/2006
BBK Technology LLC
Phoenix, AZ
BK100037 RC-AID, version 2.0 09/13/2010
BD Biosciences
San Jose, CA
BK110037 BD™ Stem Cell Enumeration Kit 10/19/2011
BD Biosciences
San Jose, CA
BK050073 BD HLA-B27 System 02/16/2006
BD Biosciences
San Jose, CA
BK050062 BD HLA-B27 kit 10/27/2005
BD Biosciences
San Jose, CA
BK030027 BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit 07/10/2003
Beckman Coulter, Inc
Miami, FL
BK040055 stemCXP System for the FC 500 with CXP Software 09/16/2004
Beckman Coulter, Inc
Miami, FL
BK040032 Stem-Kit Reagents 05/05/2004
Beckman Coulter, Inc
Miami, FL
BK020063 LeukoSure Enumeration Kit with Leuko-Trol RBC Control Cells and Leuko Trol Platelet Control Cells 02/03/2003
Beckman Coulter, Inc
Miami, FL
BK010044 stemONE System for EPICS XL/XL-MCL Flow Cytometry Systems 05/20/2002
Becton, Dickinson & Company
Franklin Lakes, NJ
BK060046 Bd.id Patient Identification System for Transfusion Management V7.00 02/13/2007
Becton, Dickinson & Company
Franklin Lakes, NJ
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
02/24/2006
Becton, Dickinson & Company
Franklin Lakes, NJ
BK040030 BD Vacutainer Plus Plastic Serum Tubes with Clot Activator 05/05/2004
Becton Dickinson Vacutainer Systems
Franklin Lakes, NJ
BK980011 VACUTAINER Brand PLUS (Plastic) Blood Collection Tube with EDTA Anticoagulant 06/07/1999
Belmont Instrument Corporation
Billerica, MA
BK150301 The Belmont buddy™ 2 Blood/Fluid Warmer 09/02/2015
BioArray Solutions LTD
Warren, NJ
BK150270 Array Imaging System (AIS) 400D 06/15/2015
BioArray Solutions, Ltd.
Warren, NJ
BK130051 BioArray™ Array Imaging System (AIS) 400C 05/21/2014
BioArray Solutions, Ltd.
Warren, NJ
BK130050 PreciseType HEA BeadCheck Kit 05/21/2014
BioErgonomics, Inc
St. Paul, MN
BK000046 FluoroTrol Control Kits 04/02/2001
Biofortuna Ltd.
Grayslake, IL
BK130028 SSPGo HLA Typing Kit 12/19/2013
BioLife Plasma Services L.P.
Deerfield, IL
BK150347 Lookback Notification System (LNS), Version 1.0 02/12/2016
BioLife Plasma Services, LP
Deerfield, IL
BK140164 Donor Information System (DIS) v7.0 10/20/2014
BioLife Plasma Services, LP
Deerfield, IL
BK120069 Automated Plasma Dispositioning System (APDS) v1.0 05/31/2013
BioLife Plasma Services, LP
Deerfield, IL
BK120064 Donor Information System (DIS) v6.0 12/19/2012
BioLife Plasma Services, LP
Deerfield, IL
BK100021 Donor Information System (DIS) Version 5.0 06/18/2010
BioLife Plasma Services, LP
Deerfield, IL
BK090001 Donor Information System (DIS) version 4.0 08/18/2009
BioLife Plasma Services LP
Deerfield, IL
BK080016 Donor Information System v3.3 07/02/2008
BioLife Plasma Services LP
Deerfield, IL
BK060017 Donor Information System (DIS) 3.2 05/09/2006
BioLife Plasma Services LP
Deerfield, IL
BK050029 Donor Information System (DIS) 3.1 07/07/2005
Biomat USA, Inc.
City of Industry, CA
BK090082 System for Plasma Identification (SPI), Version 2.0.0 10/01/2010
BioMerieux, Inc
Durham, NC
BK050037 BacT/ALERT BPA Culture Bottle 12/27/2005
BioMerieux, Inc
Durham, NC
BK050043 BacT/ALERT BPN Culture Bottle 12/27/2005
BioMerieux, Inc
Durham, NC
BK030076 BacT/ALERT BPA Culture Bottles 03/08/2004
BioMerieux, Inc
Durham, NC
BK030075 BacT/ALERT BPN Culture Bottles 03/08/2004
BioMerieux, Inc
Durham, NC
BK030034 BacT/ALERT BPN Culture Bottle 07/18/2003
BioMerieux, Inc
Durham, NC
BK020022 BacT/ALERT SN Culture Bottle 10/10/2002
BioMerieux, Inc
Durham, NC
BK020023 BacT/ALERT SA Culture Bottle 10/10/2002
BioMerieux, Inc
Durham, NC
BK000042 BacT/ALERT Culture Bottles 02/15/2002
Biomet Biologics, Incorporated
Warsaw, IN
BK110040 Clotalyst® Kit with GPS® III Platelet Separation Kit with ACD-A
Clotalyst® Kit with GPS® III Mini Platelet Separation Kit with ACD-A
12/23/2011
Biomet Biologics, Incorporated
Warsaw, IN
BK100027 BioCUE™ Platelet Concentration Kit
BioCUE™ Mini Platelet Concentration Kit
05/26/2010
Biomet Biologics, Incorporated
Warsaw, IN
BK090008 GPS® II Platelet Concentration System 12/18/2009
Biomet Biologics, Incorporated
Warsaw, IN
BK080004 Clotalyst and GPS III Platelet Concentrate Separation Kit with ACD-A
Clotalyst and GPS III Mini Platelet Concentrate Separation Kit with ACD-A
12/19/2008
Biomet,Inc.
Warsaw, IN
BK070036 Vortech® Concentration System 11/21/2007
Biomet,Inc.
Warsaw, IN
BK070026 GPS III Mini Platelet Concentrate Separation Kit with ACD-A 06/20/2007
Biomet,Inc.
Warsaw, IN
BK070003 GPS II Platelet Concentration Separation Kit with ACD-A 02/22/2007
Biomet,Inc.
Warsaw, IN
BK050016 GPS II Platelet Concentrate Separation Kit w/ Plasma Concentrator Accesory 07/20/2005
Biomet,Inc.
Warsaw, IN
BK040036 GPS II Platelet Concentrate Separation Kit 06/24/2004
Biometric Imaging, Inc
Mountain View, CA
BK970015 CEQer RBC Assay 09/18/1998
Biometric Imaging, Inc
Mountain View, CA
BK970016 CEQer PRP Assay 09/18/1998
Biometric Imaging, Inc
Mountain View, CA
BK970018 STELLer CD34 Assay 08/18/1998
Bio-Rad Laboratories
Redmond, WA
BK140112 BioPlex® 2200 System 07/23/2015
Bio-Rad Medical Diagnostics GmbH
Germany 
BK150327 TANGO infinity™ 12/16/2015
Bio-Rad Medical Diagnostics GmbH
Redmond, WA
BK130070 MLB 2 (10 x 10 mL) 11/27/2013
Biosafe SA
Switzerland
BK140203 Sepax Cell Separation System and Single Use Kits 02/13/2015
Biosafe SA
Switzerland
BK110022 Sepax Cell Separation System and Single-Use Kits, Sepax 2 S-100 10/28/2011
Biosafe SA
Alexandria, VA
BK060036 Sepax Cell Separation System and single use kits 01/03/2007
Biotechnology Institute SL
Spain
BK090069 Endoret Kit 01/29/2010
Biotest AG
Germany
BK060066 TANGO Automated Blood Bank Analyzer System, Version 3.0 Service Pack 4 01/17/2007
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
07/23/2008
Biotest Medical Diagnostics GmbH
Germany
BK080012 Seraclone Control ABO+Rh; Coombscell-E; MLB2 07/23/2008
Biotest Diagnostics Corp
Denville, NJ
BK960061 Biotest DQB-ELPHA 08/04/1997
Biotest Diagnostics Corp
Denville, NJ
BK960086 Biotest High Resolution Supplementary Kit 07/03/1997
Blackhawk BioSystems, Inc
San Ramon CA
BK060052 AmpliTrol III 11/07/2006
Blood Bank Computer Systems, Inc.
Auburn, WA
BK140198 ABO QuickPass, Version 1.0.0 02/04/2015
Blood Bank Computer Systems, Inc
Auburn, WA
BK140184 ABO Wheels 1.0.0 12/30/2014
Blood Bank Computer Systems, Inc
Auburn, WA
BK140130 ABO QuickPass, version 1.0.0 10/10/2014
Blood Bank Computer Systems, Inc
Auburn, WA
BK140142 BBCS Primary Application, version 5.4.3 10/10/2014
Blood Bank Computer Systems, Inc
Auburn, WA
BK120028 BBCS BloodTrack Interface Application (BBCSBT), BT 1.0.0
Blood Bank Control System version 5.0
06/21/2012
Blood Bank Computer Systems, Inc
Auburn, WA
BK960044 Blood Bank Control System Version 4.0/4.1/4.2/4.3 10/15/1997
Blood Bank Computer Systems, Inc
Auburn, WA
BK090081 BBCS Hospital Interface Application (BBCSH), H 1.0.0 12/23/2009
Blood Bank Computer Systems, Inc
Auburn, WA
BK050013 BBCS Mobile Application 5.0M 06/01/2005
Blood Bank Computer Systems, Inc
Auburn, WA
BK040087 BBCS Lab Interface Application (BBCS Lab) 5.0L 02/15/2005
Blood Bank Computer Systems, Inc
Auburn, WA
BK040056 Blood Bank Control System (BBCS) 5.0 10/22/2004
Boekel Scientific
Feasterville, PA 
BK100051 Boekel Scientific Plasma Thawer, Model 301000 04/22/2011
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 01/20/2000
B.T.I. Biotechnology Institute, S.L.
Spain
BK150294 Endoret® Kit 12/09/2015
B.T.I. Biotechnology Institute, S.L.
Spain
BK130049 BTI ENDORET® Kit for Platelet and Plasma Separator 01/16/2014
Back to Alphabetical Index
C
Calimex USA Corporation
Alameda, CA
BK120035 Picture - ID Version 2.0 12/17/2012
Calimex USA Corporation
Alameda, CA
BK110070 eOrders, Version 1 02/17/2012
Calimex USA Corporation
Alameda, CA
BK090054 Picture-ID 01/11/2010
Care Fusion, Inc.
McLean, VA
BK040002 wBlood Care 1.0 11/10/2004
CaridianBCT, Inc.
Lakewood, CO
BK110051 Trima Accel Automated Blood Component Collection System 12/20/2011
CaridianBCT, Inc.
Lakewood, CO
BK080029 Trima Accel®Automated Blood Component Collection System 05/18/2010
CaridianBCT, Inc.
Lakewood, CO
BK090003 Trima Accel®System 01/29/2010
CaridianBCT, Inc.
Lakewood, CO
BK080058 Trima Accel® Automated Blood Component Collection System 11/25/2008
CaridianBCT, Inc.
Lakewood, CO
BK080043 Atreus Whole Blood Processing System 09/29/2008
CaridianBCT, Inc.
Lakewood, CO
BK080035 Trima Accel Automated Blood Component Collection System, COBE Spectra Apheresis System 08/29/2008
CaridianBCT, Inc.
Lakewood, CO
BK100032 Trima Accel® Automated Blood Component Collection System 05/20/2010
Carter BloodCare
Bedford, TX
BK990015 LifeTrak / Distribution, version 2.03 10/22/1999
Carter BloodCare
Bedford, TX
BK990027 LifeTrak / Donor, version 2.03 12/15/1999
Cascade Medical Enterprises, LLC
Wayne, NJ
BK120009 FIBRINET® Autologous Platelet System- BK120009 08/01/2012
Cascade Medical Enterprises, LLC
Wayne, NJ
BK120008 FIBRINET® Autologous Platelet System- BK120008 08/01/2012
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 06/11/2003
Celera Diagnostics/Applied Biosystems, Inc
Alameda, CA
BK010024 ViroSeq HIV-1 Genotyping System 12/10/2002
Cellmedix Holdings, LLC
Watertown, MA
BK130079 Centrepid TM PC Kit 07/31/2014
Cerner Corporation
Kansas City, MO
BK060037 Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.3 05/24/2007
Cerner Corporation
Kansas City, MO
BK030028 Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 08/19/2003
Cerner Corporation
Kansas City, MO
BK950051 PathNet Blood Bank Center Version 306 07/16/1997
Cerner Corporation
Kansas City, MO
BK950053 PathNet Blood Bank Transfusion Version 306 07/16/1997
Cerner Corporation
Kansas City, MO
BK950055 PathNet Blood Bank Donor Version 306 07/16/1997
Cerner Corporation
Kansas City, MO
BK960024 PathNet Worksystems Blood Bank Transfusion Version 306 07/16/1997
Cerner Corporation
Kansas City, MO
BK990007 HNA Millennium PathNet Blood Bank Transfusion 11/02/1999
Charter Medical, Ltd
Winston-Salem, NC
BK100049 Cell-Freeze® Cryogenic Storage 12/07/2010
Charter Medical, Ltd
Winston-Salem, NC
BK050021 Charter Medical Transfer Set 07/22/2005
Charter Medical, Ltd
Winston-Salem, NC
BK060042 Cell Freeze Liquid Nitrogen Freezing Container 10/03/2008
Chiron Corporation
Emeryville, CA
BK060005 Chiron Procleix NAT Tracker 3.0 03/01/2006
Chiron Corporation
Emeryville, CA
BK050004 Procleix Optiva RAS 04/08/2005
Circle Biologic, LLC
Minneapolis, MN
BK100014 Autologous Platelet Concentrator (APC)™ System 07/09/2010
COBE Cardiovascular, Inc
Arvada, CO
BK050033 COBE Angel Whole Blood Separation System 08/22/2005
COBE BCT
Lakewood, CO
BK990025 COBE Trima 04/07/2000
COBE BCT
Lakewood, CO
BK970005 Focussed System 10/13/1998
Community Bio-Resources, Inc
Hoover, AL
BK970007 Donor Information System, Version 1.0 04/09/1997
Community Blood Centers of South Florida
Lauderhill, FL 33313
BK110048 Regulated Software Application (RSA) 01/12/2012
Community Blood Center of Greater Kansas City
Kansas City, MO
BK960060 CBC Blood System Version 1.2 11/20/1997
Computer Programs and Systems, Inc.
Mobile, AL
BK130003 Blood Administration, version 1900 04/30/2014
CSL Behring AG
Switzerland
BK110023 System for Plasma Identification (SPI), version 3.1.0 06/08/2011
Cytomedix, Incorporated
Gaithersburg, MD
BK110046 Angel® Concentrated Platelet Rich Plasma (cPRP) System 11/07/2012
Cytomedix, Inc
Rockville, MD
BK060007 AutoloGel System 09/20/2007
CytoTherm
Trenton, NJ
BK080019 CytoTherm Plasma Thawing System 07/16/2008
CytoTherm LP
Trenton, NJ
BK060027 CytoTherm Plasma Thawing System 08/01/2006
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D
Data Innovations, Inc
South Burlington, VT
BK120051 Instrument Manager v8.12 10/17/2012
Data Innovations, Inc
South Burlington, VT
BK100046 Instrument Manager v8.10 08/12/2010
Data Innovations, Inc
South Burlington, VT
BK060053 Instrument Manager 8.05.01.10 01/05/2007
Data Innovations, Inc.
South Burlington, VT
BK020057 imExpress 7.2.5 07/29/2003
DENCO, Inc
Wilmington, DE
BK000022 Total Containment Device 04/18/2000
DENCO, Inc
Wilmington, DE
BK990041 Total Containment Device TCD 12/21/1999
Department of Defense
Falls Church, VA
BK070035 Defense Blood Standard System (DBSS) 10.0.0 05/22/2008
Department of Defense
Falls Church, VA
BK960004 Defense Blood Standard System Versions 1.00/1.03 08/01/1997
Department of Defense
Falls Church, VA
BK980031 Defense Blood Standard System Version 3.00 08/31/1998
Department of Veterans Affairs
Hines, IL
BK140172 VistA Blood Establishment Computer Software (VBECS), 2.0.0 11/20/2014
Department of Veterans Affairs
Hines, IL
BK060043 VistA Blood Establishment Computer Software (VBECS) 1.0 10/19/2006
Department of Veterans Affairs
Hines, IL
BK970021 Vista Blood Bank, Version 5.2 04/23/1999
Diagnostic Grifols, S.A.
Spain
BK150266 DG Gel® 8 Neutral 07/28/2015
Diagnostic Grifols S.A.
Spain
BK140101 DG Reader 05/21/2014
Diagnostic Grifols S.A.
Spain
BK130067 Erytra® 01/17/2014
Diagnostic Grifols S.A.
Spain
BK130025 WADiana® Compact 08/30/2013
Diagnostic Grifols S.A.
Spain
BK120046 DG THERM 07/25/2012
Diagnostic Grifols S.A.
Spain
BK120045 DG SPIN 07/24/2012
Diagnostic Grifols S.A.
Spain
BK120044 Grifols Diluent 07/24/2012
Diagnostic Grifols S.A.
Spain
BK120043 DG Gel 8 Neutral 07/20/2012
Diaspect Medical GMBH
Richmond, VA
BK120052 DiaSpect Control HBT (-L, -M. -H) 11/04/2012
DiaSpect Medical GmbH
C/O Regulatory Resources, Inc.
Richmond, VA
BK110036 DiaSpect Hemoglobin T and DiaSpect Hemoglobin Cuvettes 11/01/2011
Digi-Trax Corp
Buffalo Grove, IL
BK010049 Donor-ID 2.2 04/26/2002
Digi-Trax Corp
Buffalo Grove, IL
BK000020 Digi-Trax Donor-ID 2.0 04/20/2000
Digi-Trax Corp
Buffalo Grove, IL
BK970013 DONOR-ID, version 1.0 02/27/1998
DSM Biomedical
Exton, PA
BK140176 DSM Biomedical JEN Device 03/06/2015
DSM Biomedical
Exton, PA
BK130053 DSM Biomedical PRP Device 03/25/2014
Duley Hopkins and Associates
Chattanooga, TN
BK090079 Blood Bank Information Management System (BBIMS) v2.05.01 01/13/2010
Duley Hopkins and Associates
Chattanooga, TN
BK070065 Blood Bank Information Management System (BBIMS) 04/25/2008
Dynal Biotech Ltd
United Kingdom
BK050012 Dynal RELI SSO HLA-DRB1 Typing Kit
For use as a manual assay or with the AutoRELI 48 instrument
05/18/2005
Dynal Biotech Ltd
United Kingdom
BK030056 Dynal Reli SSO HLA-A Typing Kit 01/29/2004
Dynal Biotech Ltd
United Kingdom
BK030057 Dynal Reli SSO HLA-B Typing Kit 01/29/2004
Dynal Biotech Ltd
United Kingdom
BK030058 Dynal Reli SSO HLA-Cw Typing Kit 01/29/2004
Dynal Biotech Ltd
United Kingdom
BK030059 Dynal Reli SSO HLA-DQB1 Typing Kit 01/29/2004
Dynal Biotech Ltd
United Kingdom
BK030060 Dynal Reli SSO HLA-DRB Typing System 01/29/2004
Dynamic Healthcare Technologies, Inc
Maitland, FL
BK960041 Transfusion Service Manager, Version 4.1.6 12/16/1997
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E
Eclipsys Corporation
Malvern, PA
BK090044 Sunrise Blood Bank version 2.0 SP2 11/13/2009
Epic Systems Corporation
Verona, WI
BK130037 Blood Product Administration Module, version 0.9 03/06/2014
Estar Technologies Ltd.
New York, NY
BK110035 TropoCells Autologous Platelet Preparation Kit Regulation 03/28/2012
Ethicon, Inc.
Somerville, NJ
BK140093 EvicelTMApplication Device 09/03/2014
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F
Fenwal Inc.
Lake Zurich, IL
BK150236 Alyx 2RBC Closed Disposable Apheresis Kit 04/22/2015
Fenwal Inc.
Lake Zurich, IL
BK130030 Alyx Component Collection System 11/01/2013
Fenwal Inc.
Lake Zurich, IL
BK130004 ALYX Component Collection System 09/11/2013
Fenwal Inc.
Lake Zurich, IL
BK120082 AMICUS Apheresis Kits
AMICUS Separator System
01/08/2013
Fenwal Inc.
Lake Zurich, IL
BK120047 Autopheresis-C Plasampheresis System Plasmacell-C Set
 
12/18/2012
Fenwal Inc.
Lake Zurich, IL
BK120041 AMICUS Separator System;
ALYX Component System
09/25/2012
Fenwal Inc.
Lake Zurich, IL
BK120018 AMICUS Separator System
AMICUS Apheresis Kits
07/20/2012
Fenwal Inc.
Lake Zurich, IL
BK110072 Aurora Plasmapheresis System;
Plasmacell-C Disposable Set
03/29/2012
Fenwal Inc.
Lake Zurich, IL
BK110066 Product Sample Pack 02/27/2012
Fenwal Inc.
Lake Zurich, IL
BK110030 AMICUS Separator System with Software Version 4.3 12/23/2011
Fenwal Inc.
Lake Zurich, IL
BK110025 Fenwal DXT Relay, Software Version 2.0 08/22/2011
Fenwal Inc.
Lake Zurich, IL
BK100056 ALYX® Component Collection System 12/07/2010
Fenwal Inc.
Lake Zurich, IL
BK100050 Autopheresis-C™ Plasmapheresis System 11/16/2010
Fenwal Inc.
Lake Zurich, IL
BK100041 Autopheresis-C™ Plasmapheresis System 08/05/2010
Fenwal Inc.
Lake Zurich, IL
BK100044 AMICUS® Separator System 07/30/2010
Fenwal Inc.
Lake Zurich, IL
BK090065 AMICUS® SeparatorSystem 01/27/2010
Fenwal Inc.
Lake Zurich, IL
BK090058 AMICUS® SeparatorSystem 02/18/2010
Fenwal Inc.
Lake Zurich, IL
BK090031 Bone Marrow Collection/Transfusion Kit 07/23/2009
Fenwal Inc.
Lake Zurich, IL
BK080053 ALYX Component Collection System 12/22/2008
Fenwal Inc.
Lake Zurich, IL
BK080048 AMICUS® Separator: Software 3.1 with EDI Export 10/02/2008
Fenwal Inc.
Lake Zurich, IL
BK080018 Amicus Separator System 08/26/2008
Fenwal Inc.
Lake Zurich, IL
BK080033 PLASMALINK 08/22/2008
Fenwal Inc.
Lake Zurich, IL
BK080024 ALYX Component Collection System 06/24/2008
Fifth Dimension Information Systems
Canada
BK050060 E-Interview (eQue) 1.0.0 05/24/2006
Fifth Dimension Information Systems
Canada
BK040040 LOGIC 2.0 10/06/2004
Fifth Dimension Information Systems
Canada
BK020058 LOGIC 1.0 02/03/2003
Fifth Dimension Information Systems
Canada
BK000026 P2K Plasma Center Module 2000 Version 1.0 06/22/2000
Fifth Dimension Information Systems
CANADA
BK990022 Donor Management System, version 1.0.0 09/10/1999
Fifth Dimension Information Systems
Canada
BK980025 Plasma Center Module, Version 1.0 05/18/1999
Fresenius Hemocare Inc
Lexington, MA
BK040076 Compodock 12/17/2004
Fresenius Hemocare Inc
Lexington, MA
BK040005 Fresenius Compoguard & Donationmaster NT 03/26/2004
Fresenius Hemocare Inc
Redmond, WA
BK030022 Fresenius Compomat G4 & Compomaster NT 07/11/2003
Fresenius Kabi USA LLC
Lake Zurich, IL
BK150357 Amicus Separator System 4/20/2016
Fresenius Kabi USA LLC
Lake Zurich, IL
BK150288 Amicus Separator System 08/28/2015
Fresenius Kabi USA LLC
Lake Zurich, IL
BK150242 Amicus Separator System 07/22/2015
Fresenius Kabi, LLC.
Schaumburg, IL
BK110012 CompoMat G5 and CompoMaster Net G5 System 08/02/2012
Fujirebio Diagnostics, Inc
Malvern, PA
BK070030 Olympus PK CMV-PA Test System and Controls for the Olympus PK7300 Automated Blood Bank Analyzer 09/20/2007
Fujirebio Diagnostics, Inc
Malvern, PA
BK060062 Olympus PK TP Reagent System 06/25/2007
Fujirebio Diagnostics, Inc
Malvern, PA
BK030007 Olympus PK TP System 02/21/2003
Back to Alphabetical Index
G
Gambro BCT, Inc
Lakewood, CO
BK080010 The Atreus Whole Blood Processing System 06/27/2008
Gambro BCT, Inc
Lakewood, CO
BK070066 Vista Information System, Version 3.0 with Medical Review Module 12/13/2007
Gambro BCT, Inc
Lakewood, CO
BK040086 COBE Spectra Apheresis System & Trima Automated Blood Component Collection System 03/15/2005
Gambro BCT, Inc
Lakewood, CO
BK040069 Trima Automated Blood Component Collection System - Blood Component Sampling Accessary 10/28/2004
Gambro BCT, Inc
Lakewood, CO
BK010037 Platelet collection sets for the COBE Spectra Apheresis System and the Trima Automated Blood Component Collection System 09/24/2003
Gambro BCT, Inc
Lakewood, CO
BK030021 Vista Information System 2.1 05/01/2003
Gambro BCT, Inc
Lakewood, CO
BK020041 COBE Spectra Apheresis System/Blood component disposable collection sets for apheresis 04/23/2003
Gambro BCT, Inc
Lakewood, CO
BK010050 Trima Automated Blood Collection System 09/18/2002
Gambro BCT, Inc
Lakewood, CO
BK010046 Trima Automated Blood Collection System (Single Stage) 09/18/2002
Gambro BCT, Inc
Lakewood, CO
BK020015 Vista Information System, Independent Solution 07/15/2002
Gambro BCT, Inc
Lakewood, CO
BK010006 Trima Automated Blood Component Collection System 02/27/2002
Gaymar Industries, Inc
Washington, DC
BK060050 Medi-Temp III, Model FW600 Blood/Fluid Warmer 11/07/2006
GE Medical Information Technologies
Barrington, IL
BK050018 Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 06/13/2005
Genesis BPS, LLC
Ramsey, NJ
BK140187 Genesis Rapid Weld STW Sterile Tube Welder 03/06/2015
Genetic Testing Institute
Brookfield, WI
BK960059 PAKAUTO Platelet Antibody Screening Kit 10/22/1998
Genetic Testing Institute
Brookfield, WI
BK000031 GTI-MACE (Modified Capture ELISA) 01/29/2001
Gen-Probe, Inc
San Diego, CA
BK060021 Procleix TIGRIS System for use with the Procleix WNV Assay 02/20/2007
Gen-Probe GTI Diagnostics
Waukesha, WI
BK110011 LIFECODES Class II ID v2 06/04/2012
Gen-Probe Transplant Diagnostics, Inc.
Stamford, CT
BK110002 LIFECODES HLA-A eRES Typing Kit for use with Luminex
LIFECODES HLA-B eRES Typing Kit for use with Luminex
LIFECODES HLA-DRB1 eRES Typing Kit for use with Luminex
LIFECODES HLA-DRB 3, 4, 5 Typing Kit for use with Luminex
12/12/2011
Gen-Probe Transplant Diagnostics, Inc.
Stamford, CT
BK120063 LIFECODES HLA-C eRES Typing Kit for use with Luminex 11/21/2012
Greiner Bio-One North America, Inc.
Monroe, NC
BK050026 Greiner Vacuette No Additive Tubes 07/07/2005
Greiner Bio-One North America, Inc.
Monroe, NC
BK050028 Greiner Vacuette Clot Activator Tube 07/07/2005
Greiner Bio-One GmbH
Westmont, IL
BK030032 Greiner Vacuette EDTA K2 Evacuated Blood Collection Tube 07/18/2003
Greiner Bio-One GmbH
Westmont, IL
BK030001 Greiner Vacuette EDTA K3 Tube 02/26/2003
Grifols Diagnostic Solutions Inc.
Emeryville, CA
BK140150 Procleix Xpress® System 08/27/2014
GTI, INC
Waukesha, WI
BK070045 Donor Screen HLA Class I and Class II 07/30/2008
GTI, INC
Waukesha, WI
BK060038 MICROAMS 07/28/2006
GTI, INC
Waukesha, WI
BK050054 GranType 03/02/2006
GTI, INC
Waukesha, WI
BK050040 ThromboType (HPA 1-6, 15) and ThromboType 1 (HPA 1) 01/20/2006
GTI, INC
Waukesha, WI
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 07/16/2004
GTI, INC
Waukesha, WI
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
07/16/2004
GTI, INC
Waukesha, WI
BK040019 Antibody Monitoring System Class 1 and Class II (AMS1 and AMS1+2) 07/06/2004
Back to Alphabetical Index
H
Haemonetics Corporation
Briantree, MA
BK150287 Haemonetics MCS + 8150 Apheresis System 07/28/2015
Haemonetics Corporation
Braintree, MA
BK150292 Haemonetics PCS2 Plasma Collection System 07/31/2015
Haemonetics Corporation
Braintree, MA
BK130056 Haemonetics PCS2 Plasma Collection System 08/29/2014
Haemonetics Corporation
Braintree, MA
BK140108 MCS+ 8150 System-Wireless 08/26/2014
Haemonetics Corp
Braintree, MA
BK130081 Cymbal Automated Blood Collection System 01/22/2014
Haemonetics Corp
Braintree, MA
BK120065 PCS2 Plasma Collection System software revision K.1 11/26/2012
Haemonetics Corp
Braintree, MA
BK120002 LOGIC Version 3.0.0 04/24/2012
Haemonetics Corp
Braintree, MA
BK110015 Nextgen, version 1.0.0 06/13/2011
Haemonetics Corp
Braintree, MA
BK090083 Cymbal Automated Blood Collection System 01/27/2010
Haemonetics Corp
Braintree, MA
BK090041 Symphony System 3.0 09/28/2009
Haemonetics Corp
Braintree, MA
BK090004 MCS+8150 System - Wireless 02/20/2009
Haemonetics Corp
Braintree, MA
BK080038 MCS+ 9000 System 09/04/2008
Haemonetics Corp
Braintree, MA
BK080025 Cymbal Automated Blood Collection System 08/15/2008
Haemonetics Corp
Braintree, MA
BK080001 PCS2 Plasma Collection System_Revision K software 05/28/2008
Haemonetics Corporation
Braintree, MA
BK060033 Haemonetics PCS 2 Plasma Collection System, Wireless (W) Capable Modification 03/27/2008
Haemonetics Corp
Braintree, MA
BK060008 Haemonetics ACP 215 Glycerolization/Deglycerolization System 05/23/2006
Haemonetics Corp
Braintree, MA
BK050047 MCS+9000, SDP revision E software, 994CF-CPP series disposable sets 11/21/2005
Haemonetics Corp
Braintree, MA
BK050006 ACP 215 Glycerolization/Deglycerolization System 04/14/2005
Haemonetics Corp
Braintree, MA
BK040077 Haemonetics Model 215 Automated Glycerolization/Deglycerolization System 12/21/2004
Haemonetics Corp
Braintree, MA
BK040041 Haemonetics MCS+8150 Apheresis System 07/12/2004
Haemonetics Corp
Braintree, MA
BK040025 PCS2 Plasma Collection System 06/02/2004
Haemonetics Corp
Braintree, MA
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
BK040001 Haemonetics 4mL Sampling System 02/27/2004
Haemonetics Corp
Braintree, MA
BK030062 Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation System 12/10/2003
Haemonetics Corp
Braintree, MA
BK030031 Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation and Cell Washing System 09/10/2003
Haemonetics Corp
Braintree, MA
BK010035 MCS+ Mobile Collection System 12/20/2002
Haemonetics Corp
Braintree, MA
BK020001 Plasma Pooling Bottle II 03/29/2002
Haemonetics Corp
Braintree, MA
BK000002 Model 215 Automated Glycerlization and Deglycerolization System 05/04/2001
Haemonetics Corp
Braintree, MA
BK000048 Haemonetics LN832F 04/09/2001
Haemonetics Corp
Braintree, MA
BK990033 MCS+ LN8150 Red Cell Apheresis Instrument 01/20/2000
Haemonetics Corporation
El Dorado Hills, CA
BK150308 ElDorado Donor 3.0.0 11/20/2015
Haemonetics Corporation Software Solutions
Eldorado Hills, CA
BK150360 SafeTrace Tx 3.12.0 03/11/2016
Haemonetics Corporation Software Solutions
Eldorado Hills, CA
BK150330 NextGen 3.0.0 03/03/2016
Haemonetics Corporation Software Solutions
El Dorado Hills, CA
BK140199 Surround 5.1 02/05/2015
Haemonetics Corporation Software Solutions
El Dorado Hills, CA
BK140183 Donor Doc 3.0.0 12/10/2014
Haemonetics Corporation Software Solutions
El Dorado Hills, CA
BK140166 Cross Donation Check System (CDCS) 1.0.0 10/10/2014
Haemonetics Corporation Software Solutions
El Dorado Hills, CA
BK140133 BloodTrack 4.7.0 08/29/2014
Haemonetics Software Solutions
El Dorado Hills, CA
BK130082 NextGen v2.0.0 08/08/2014
Haemonetics Software Solutions
El Dorado Hills, CA
BK120084 Phlebotomy System 1.0.0 04/30/2013
Harvest Technologies
Plymouth, MA
BK130068 Harvest Technologies PRP Separation System with LP-10 03/24/2014
Harvest Technologies
Plymouth, MA
BK120038 Harvest PRP Separation System with ACD-A (30 mL) 09/25/2012
Harvest Technologies
Plymouth, MA
BK100059 Harvest PRP Separation System with ACD-A (30 ml) 11/18/2010
Harvest Technologies
Norwell, MA
BK000037 Harvest PRP Separation System 02/05/2001
Healthcare-ID, Inc.
Buffalo Grove, IL
BK140149 Donor-ID™ version 3.2.6 01/23/2015
Healthcare-ID, Inc.
Buffalo Grove, IL
BK150279 Donor-ID 3.2 (integrated with iniCASI App iOS technology, optional) 11/12/2015
Healthcare-ID
Buffalo Grove, IL
BK120030 Donor-ID™ Web Version 3.2 integrated with biometric finger identification technology, optional 06/25/2012
Healthcare-ID
Buffalo Grove, IL
BK080044 Donor-ID Web™, version 3.1.4 06/10/2009
Healthcare-ID
Buffalo Grove, IL
BK060058 Donor-ID 3.0 02/08/2007
Healthcare-ID
Buffalo Grove, IL
BK030049 Donor-ID 10/31/2003
Healthcare Management Systems, Inc
Nashville, TN
BK090025 HMS Blood Administration Module, Release 9.0 02/23/2010
Healthcare Management Systems, Inc
Nashville, TN
BK050001 Monitor Blood Administration Module Release 24.0 09/28/2005
Helmer Labs, Inc
Noblesville, IN
BK020029 UltraCW (with Software version 3.13) 10/04/2002
Hemasoft Software SL
Madrid, Spain
BK150300 e-Delphyn Blood Management Software version 7.1.0.0 10/24/2015
Hemasure, Inc
Marlborough, MA
BK980014 HemaSure r|LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells 05/27/1999
Hemerus Medical, LLC
Saint Paul, MN
BK080031 HEMERUS LEUKOSEP ® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells 09/11/2008
Hemo bioscience, Inc
Durham, NC
BK140161 Hemo-QC 09/08/2014
Hemo Bioscience
Durham, NC 27713
BK120022 C3 Control Cells 10/24/2012
HemoCue AB
Sweden
BK060048 HemoCue Hb 301 System 10/05/2006
HemoCue, Inc
Potomac, MD
BK030067 HemoCue Donor Hb Checker System 12/19/2003
HemoCue, Inc
Potomac, MD
BK030020 Donor Hemoglobin Checker System 04/17/2003
HemoCue, Inc
Potomac, MD
BK000043 HemoCue Low Hemoglobin Analyzing System 04/09/2001
Hemosystem, S.A.
Richmond, VA
BK040031 Scansytem Bacterial Detection Device 09/23/2004
Back to Alphabetical Index
I
Immucor, Inc
Norcross, GA
BK150333 ImmuLINK, V.1.7 11/19/2015
Immucor, Inc
Norcross, GA
BK120021 TPHA Screen 10/24/2012
Immucor, Inc
Norcross, GA
BK120016 ImmuLINK, version 2.0 06/14/2012
Immucor, Inc
Norcross, GA
BK110067 FMH RapidScreen 05/22/2012
Immucor, Inc
Norcross, GA
BK110050 Checkcell
Checkcell (Weak)
DAT Positive Control Cell
10/03/2011
Immucor, Inc
Norcross, GA
BK100033 Galileo NeoTM Automated Blood Bank System 08/23/2010
Immucor, Inc
Norcross, GA
BK090057 Galileo® 07/09/2010
Immucor, Inc
Norcross, GA
BK100001 Galileo Neo 04/29/2010
Immucor, Inc
Norcross, GA
BK080070 Galileo® Automated Blood Bank System 02/05/2009
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 09/28/2007
Immucor, Inc
Norcross, GA
BK070016 Galileo Echo Automated Blood Bank System 06/14/2007
Immucor, Inc
Norcross, GA
BK070015 WB corQC 06/14/2007
Immucor, Inc
Norcross, GA
BK070014 DAT Positive Control Cell 06/14/2007
Immucor, Inc
Norcross, GA
BK070013 Monoclonal Control 06/14/2007
Immucor, Inc
Norcross, GA
BK060009 Galileo Automated Blood Bank System with Capture-S Syphilis Screening 04/11/2006
Immucor, Inc
Norcross, GA
BK050050 Galileo Automated Blood Bank System Capture-CMV 11/14/2005
Immucor, Inc
Norcross, GA
BK040057 Check cell (Weak) 10/06/2004
Immucor, Inc
Norcross, GA
BK040024 Capture-R Select Solid Phase System 04/28/2004
Immucor, Inc
Norcross, GA
BK040013 Galileo version 1.3.6 SP4/DMS version 1.26 04/23/2004
Immucor, Inc
Norcross, GA
BK000024 ABS2000, Version 2 software (2.05.00A and 2.0500B) 07/03/2001
Immucor, Inc
Norcross, GA
BK960019 ABS2000 06/30/1998
Immucor GTI Diagnostics, Inc.
Waukesha, WI
BK160035 LIFECODES LifeScreen Deluxe (LMX) 04/21/2016
Immucor GTI Diagnostics, Inc.
Waukesha, WI
BK140163 PakPlus® Assay 04/27/2015
Immucor GTI Diagnostics, Inc.
Waukesha, WI
BK130046 LIFECODES® LifeScreen Deluxe (LMX) 09/23/2013
Immucor Transplant Diagnostics, Inc.
Stamford, CT
BK130075 LIFECODES HLA-A SSO Typing Kit for use with Luminex
LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex
LIFECODES HLA-B SSO Typing Kit for use with Luminex
LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex
LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex
LIFECODES HLA-DQB SSO Typing Kit for use with Luminex
LIFECODES HLA-DRB1 SSO Typing Kit for use with Luminex
LIFECODES HLA-DRB1 eRES SSO Typing Kit for use with Luminex
LIFECODES HLA-DRB 3, 4, 5 SSO Typing Kit for use with Luminex
12/24/2013
Immunetics, Inc.
Boston, MA
BK130017 BacTx® Bacterial Detection Kit for Platelets 08/12/2013
Immunetics, Inc.
Boston, MA
BK110054 BacTx® Bacterial Detection Kit for Platelets 06/11/2012
Indico, Inc
Canada
BK000008 RadTag X-ray 03/01/2000
Information Data Management, Inc
Rosemont, IL
BK070031 IDM Symphony System 2.0 12/13/2007
Information Data Management, Inc
Rosemont, IL
BK050014 IDM Prelude System, Version 1.1 07/18/2005
Information Data Management, Inc
Rosemont, IL
BK020038 Surround System, Version 3.2 10/08/2002
Information Data Management, Inc
Rosemont, IL
BK010028 IDM Surround System 3.0 08/30/2001
Information Data Management, Inc
Rosemont, IL
BK000016 Information Data Management Surround System 2.0 04/07/2000
Information Data Management, Inc
Rosemont, IL
BK990046 Plasma Center Management System (PCMS), Version 2.0 01/06/2000
Information Data Management, Inc
Rosemont, IL
BK990029 Plasma Center Management System (PCMS), Version 1.2 10/13/1999
Information Data Management, Inc
Rosemont, IL
BK990016 Surround System 1.0 08/27/1999
Information Data Management, Inc
Rosemont, IL
BK980028 Plasma Center Management System Version 1.1 09/04/1998
Information Data Management, Inc
Rosemont, IL
BK980020 Plasma Center Management System Version 1.0 07/31/1998
Information Data Management, Inc
Rosemont, IL
BK950037 Components & Distribution Information System 08/26/1996
Information Data Management, Inc
Rosemont, IL
BK950045 Donor Management Information Systems, vers.1.2 08/26/1996
Informedics, Inc
Lake Oswego, OR
BK950064 Lifeline Blood Bank Management System Release 4.2 07/01/1998
Infra-Med Technologies, Inc
Dallas, TX
BK990018 Hot Shot Fluid Warmer 10/13/1999
IntelliDOT Corporation
San Diego, CA
BK080006 IntelliDOT Blood Product Administration 06/13/2008
Intra-Lock International
Boca Raton, FL
BK120048 Intra-Spin System 01/28/2013
Invitrogen Corp
Brown Deer, WI
BK070038 AllSet Gold SSP 09/26/2007
ITL Corporation, Ltd
Australia
BK980008 Bloodpack Needle Protector (BNP) 04/07/1998
IT Synergistics, LLC
Flowood, MS
BK140091 DoVac Elite v2.0 04/09/2014
IT Synergistics, LLC
Flowood, MS
BK110064 DoVac Elite v1.0 09/06/2012
Back to Alphabetical Index
K
Kaylight Corporation
Irvine, CA
BK080057 MyCells Autologous Platelet Preparation Kit 09/24/2009
Korchek Technologies, LLC
Trumbull, CT
BK040053 CareChek Patient Identification System, CareChek, Version 1.0 08/12/2005
Kowa Company, Ltd
Rockville, MD
BK030037 LD-2000 Leukocyte Counter 06/14/2004
Back to Alphabetical Index
L
Lattice, Inc.
Wheaton, IL
BK110055 MediCopia Transfusion v4.1 01/06/2012
Level 1 Technologies, Inc
Rockland, MA
BK020043 Level 1 Fluid warming System 06/16/2003
LifeSouth Community Blood Centers, Inc.
Gainesville, FL
BK160004 Integrated Blood Bank Information System (IBBIS), Version 4.0 03/29/2016
LifeSouth Community Blood Centers Inc
Gainesville, FL
BK130054 Integrated Blood Bank Information System, Version 3.0 (IBBIS) 01/17/2014
LifeSouth Community Blood Centers Inc
Gainesville, FL
BK090064 Integrated Blood Bank Information System (IBBIS) Registration Module v2.0 12/08/2009
Life Technologies Corporation
Brown Deer, WI
BK110038 SeCore® HLA Sequencing System
uType® Dx HLA Sequence Analysis Software v 1.0
02/05/2013
Life Technologies Corporation
Brown Deer, WI
BK110039 Applied Biosystems 3500 Dx/3500xL Dx Genetic Analyzer CS2 and 3500 Dx Series Data Collection Software 02/05/2013
LifeSouth Community Blood Centers Inc
Gainesville, FL
BK080017 Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 08/05/2008
LifeTrak/BloodCare
Dallas, TX
BK940048 Lab Version 2.01 10/01/1998
Ljungber & Kogel
Deerfield, IL
BK090010 Biomixer BM330 with XBee (Wireless) Option 07/17/2009
Ljungber & Kogel
Deerfield, IL
BK990013 Biomixer 330 & Biomixer 323 07/07/1999
Back to Alphabetical Index
M
MacoProductions S.A.S.
Marietta, GA
BK080060 Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells 01/15/2009
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 05/02/2003
MAK System
France
BK960050 Progesa, Version 4.4a 12/10/1998
MAK System SAS International Group
France
BK080002 ePROGESA v5.0.1 05/13/2008
MAK-System
France
BK070062 PROGESA 4.4h 10/26/2007
MAK-System
France
BK060035 Patient Health Software 1.0 05/09/2007
McKesson Provider Technologies
Alpharetta, GA
BK090051 Horizon MobileCare Transfusion 05/28/2010
Medical Information Technology
Westwood, MA
BK960029 Meditech Magic Blood Bank, Version 4.5/4.6 03/19/1999
Medion Grifols Diagnostics AG
Switzerland
BK140092 DG Gel Extended Control 04/11/2014
MEDITECH Medical Information Technology, Inc.
Westwood, MA
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 02/08/2000
Mediware Information Systems, Inc.
Oak Brook, IL
BK120036 HCLL™ Transfusion, Version 2012 09/12/2012
Mediware Information Systems, Inc.
Oak Brook, IL
BK120039 LifeTrak® Version 2012 09/05/2012
Mediware Information Systems, Inc.
Oak Brook, IL
BK100069 LifeTrak®/ Plasma, Version 1.0.0 03/04/2011
Mediware Information Systems, Inc.
Lenexa, KS
BK100057 LifeTrak®/ Lab and Distribution, Version 4.6.0 11/16/2010
Mediware Information Systems, Inc.
Lenexa, KS
BK100043 LifeTrak®/Donor, Version 4.6.0 10/21/2010
Mediware Information Systems, Inc.
Lenexa, KS
BK080061 HCLLTM Donor, version 2.0 12/02/2008
Mediware Information Systems, Inc.
Oak Brook, IL
BK080049 HCLL Transfusion, v3.0 10/22/2008
Mediware Information Systems, Inc.
Irving, TX
BK060019 LifeTrak / Donor 3.01 06/21/2006
Mediware Information Systems, Inc.
Irving, TX
BK050011 HCLL Donor 1.0 05/10/2005
Mediware Information Systems, Inc.
Irving, TX
BK040047 Instrument Interface Engine 1.0 07/16/2004
Mediware Information Systems, Inc.
Irving, TX
BK030078 HCLL 2.6 04/08/2004
Mediware Information Systems, Inc.
Dallas, TX
BK010052 LifeTrak Lab 2.03 06/17/2002
Mediware Information Systems, Inc.
Dallas, TX
BK020046 Hemocare LifeLine Version, 1.0 02/14/2003
Mediware Information Systems, Inc.
Melville, NY
BK980034 Hemocare Blood Bank Management System Version 5.2 12/10/1998
Medsep Corporation
Covina, CA
BK120026 Pall® Celeris™ fPC System 06/29/2012
Medsep Corporation
Covina, CA
BK090007 Pall ® Acrodose TM PL System 02/25/2009
Medsep Corp
Pepper Pike, OH
BK080003 Pall® AcrodoseT PLus System, Platelet Pool and Store Set with in-Line Leukocyte Reduction Filter 04/18/2008
Medsep Corporation
Covina, CA
BK070057 Pall® Acrodose PLus System Platelet Pool and Store Set with in-line Leukocyte Reduction Filter 09/27/2007
Medsep Corporation
Covina, CA
BK070056 Pall® Acrodose PLus System Platelet Pool and Store Set with in-line Leukocyte Reduction Filter and eBDS 09/27/2007
Medsep Corp
Covina, CA
BK070004 Pall eBDS 06/26/2007
Medsep Corp
Pepper Pike, OH
BK050074 Pall Acrodose PL System 01/26/2006
Medsep Corp
Covina, CA
BK050034 Pall Acrodose PL System, Platelet Pool and Store Set with eBDS 09/28/2005
Medsep Corp
Covina, CA
BK020014 Pall Bacterial Detection System (BDS) 10/22/2002
Medsep Corp
Covina, CA
BK000032 Modified Plasma Bag 09/27/2000
Medsep Corp
Covina, CA
BK970040 Medsep Plasma Bag (EVA Plastic) 01/23/1998
Medserv, Inc
Mount Kisco, NY
BK010032 Plasmapheresis Data System III 1.0 02/05/2002
Medtronic Sofamor Danek
Memphis, TN
BK040068 Magellan Autologous Platelet Separator System 11/09/2004
Medtronic Sofamor Danek
Memphis, TN
BK030040 Magellan Autologous Platelet Separation System 09/03/2003
Micro Typing Systems, Inc.
Pompano Beach, FL
BK150280 MTS Buffered Gel Card; MTS Monoclonal Control Card 08/14/2015
Micro Typing Systems Inc.
Pompano Beach, FL
BK110029 ORTHO ProVue ®, version 3.1 Patch 1 (V3.1.1) 07/14/2011
Micro Typing Systems Inc.
Pompano Beach, FL
BK090013 Ortho ProVue™, Software Version 3.1 06/04/2009
Micro Typing Systems Inc.
Pompano Beach, FL
BK030023 Ortho ProVue, Software Version: 2.10 05/30/2003
Micronics, Inc.
Redmond, WA
BK100008 ABORhCard® 04/30/2010
Microwave Medical System
Acton, MA
BK970045 ThermoStat 900 Blood & IV Fluid Adm. Set 03/06/1998
Microwave Medical System
Acton, MA
BK970044 ThermoStat 900 01/23/1998
Miltenyi Biotec, Incorporated
Woburn, MA
BK090020 CryoMACS Freezing Bag 01/13/2010
Mississippi Blood Services, Inc.
Jackson, MS
BK030065 WebLab Online Laboratory System 2.0 12/22/2003
Misys Healthcare Systems
Tucson, AZ
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 03/30/2007
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N
NanoEntek Inc.
Newton, MA
BK120068 ADAM-rWBC 12/5/2012
NanoEntek Inc.
Newton, MA
BK120015 ADAM-rWBC 07/24/2012
Neoteric Technology Ltd
Canada
BK060041 BloodTrack 4.1 10/17/2006
Neoteric Technology Ltd
Canada
BK050032 BloodTrack SafeTx Version 2.0 08/16/2005
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O
Olerup SSP AB
Gaithersburg, MD
BK080022 Olerup SSP®HLA Typing Kits 02/20/2009
Olympus America Inc
Center Valley, PA
BK090036 Olympus PK7300 Automated Microplate System 07/27/2009
Olympus America Inc
Irving, TX
BK050076 TANGO Automated Blood Bank Analyzer System (HW Version 02/SW Version 3.0) 12/16/2005
Olympus America Inc
Irving, TX
BK040070 Tango Automated Blood Bank Analyzer System 03/22/2005
One Lambda, Inc.
Canoga Park, CA
BK120014 HLA Fusion™ Software, Version 3.0 03/22/2016
One Lambda, Inc.
Canoga Park, CA
BK070070 HLA Fusion Software v 1.0 03/22/2016
One Lambda, Inc
Canoga Park, CA
BK140141 LABScreen® Multi 11/25/2014
One Lambda, Inc
Canoga Park, CA
BK130009 LABScreen® for use with LABScanTM3D 11/06/2013
One Lambda, Inc
Canoga Park, CA
BK120024 LABType ® SSO DNA Typing Tests for use with LABScan™3D 12/20/2012
One Lambda, Inc
Canoga Park, CA
BK100068 HNA Genotyping Trays 08/25/2011
One Lambda, Inc
Canoga Park, CA
BK080071 LABScreen® Multi 04/10/2009
One Lambda, Inc
Canoga Park, CA
BK050070 HLA Visual Software version 1.0 01/30/2006
One Lambda, Inc
Canoga Park, CA
BK050071 HLATools Software, Version 1.0 01/30/2006
One Lambda, Inc
Canoga Park, CA
BK050008 LABScreen Software 07/08/2005
One Lambda, Inc
Canoga Park, CA
BK040049 LabType Visual 08/09/2004
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 07/23/1999
One Lambda, Inc
Canoga Park, CA
BK960062 Micro SSP HLA Class II DNA typing Kit 02/11/1998
OriGen BioMedical
Austin, TX
BK030036 OriGen Cryostore Freezing Bags 10/01/2003
Ortho-Clinical Diagnostic, Inc.
Raritan, NJ
BK140207 ORTHO VISION™ Analyzer 08/14/2015
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK130032 ORTHO™ Workstation 08/09/2013
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK130006 ORTHO VERSEIA® Integrated Processor (VIP) as part of the ORTHO® Summit System (OSS) 5/23/2013
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK120006 ORTHO VERSEIA® Pipetter as Part of the ORTHO® Summit 03/15/2012
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK110026 ORTHO® Summit System 06/28/2011
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK100061 ORTHO VERSEIA™ Pipetter as part of the ORTHO® Summit System 10/28/2010
Ortho-Clinical Diagnostics, Inc
Rochester, NY
BK100040 VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls 06/17/2010
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK090074 Ortho Verseia™ Pipetter as part of the Ortho Summit™ System 05/29/2009
Ortho-Clinical Diagnostics, Inc
Rochester, NY
BK070028 VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls 04/10/2008
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK990030 Ortho Lab with Ortho Lab IC (Instrument Concentrator) 04/03/2000
Back to Alphabetical Index
P
Pall Life Sciences
Port Washington, NY
BK080014 Pall eBDS 02/13/2009
Patient Safe™ Solutions, Inc.
San Diego, CA 92121
BK120029 Patient Touch™ Blood Product Administration System v3.2.1 11/13/2012
Pel-Freez Clinical Systems, LLC
Brown Deer, WI
BK000019 UniTray SSP HLA Typing Kits 01/29/2001
Pel-Freez Clinical Systems, LLC
Brown Deer, WI
BK030003 UniMatch Plus 02/25/2003
Perfusion Partners & Associates, Inc
Fort Myers, FL
BK050055 GenesisCS Component Concentrating System 10/13/2006
Prescott Ideas LLC
Tucson, AZ
BK060056 Antibody Check 4.1 04/23/2007
ProFibrix BV
Seattle, WA
BK140119 RaplixaSpray Device 04/30/2015
Psyche Systems Corp
Wellesley, MA
BK010017 System Blood Bank (SBB) Software 3.0 09/04/2001
Back to Alphabetical Index
R
R & D Systems, Inc
Minneapolis, MN
BK040063 R & D Plasma Hemoglobin Hematology Control 09/17/2004
R & D Systems, Inc
Minneapolis, MN
BK040012 R&D Donor Checker Hematology Control 03/05/2004
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
BK030073 Configurable Manual Batch Entry, Version 1.1A 01/14/2004
Rubin & Poor, Inc
Maplewood, NJ
BK010025 Chiron Procleix NAT Tracker 1.0E 01/03/2002
Rubin & Poor, Inc
Maplewood, NJ
BK000030 Configurable Laboratory Result Manager (CLRM) 1.0E 11/23/2001
Rubin & Poor, Inc
Maplewood, NJ
BK080028 Pool Results Manager Version 1.0C, Module for Roche NAT Testing Version 2.0A 09/03/2008
Rubin & Poor, Inc
Maplewood, NJ
BK990008 Rubin & Poor Configurable Manual Blot System 1.0C 10/29/1999
Rowny Systems, Inc.
Bethesda, MD
BK110045 Antigen Plus Version 7.4 05/25/2012
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S
Sanguin International Limited
Hambden, CT
BK100030 Sanguin Liberty SRIMPORT 3.1 07/08/2010
Sanguin International Limited
Hambden, CT
BK090061 Sanguin Aurora Version 2.0 12/22/2009
Sanguin International Limited
Hambden, CT
BK980003 Aurora / Fenestra 1.0 09/29/1999
Sanguin International Limited
Hambden, CT
BK980039 Medussa 2000 Srimport, version 1.2 06/11/1999
Sarstedt, Inc
Newton, NC
BK070029 S-Monovette ACD-A Blood Collection System 09/21/2007
Sarstedt, Inc
Newton, NC
BK030006 Transwaag Disk 01 02/27/2003
Sarstedt, Inc
Newton, NC
BK010045 Sahara Blood & Plasma Warming Device 12/21/2001
Sarstedt, Inc
Newton, NC
BK010042 Transwaag KL 12/12/2001
SCC Soft Computer
Clearwater, FL
BK140128 SoftBank version 25.5 08/05/2014
SCC Soft Computer
Clearwater, FL
BK100045 SoftBank® II Version 25.1 07/29/2010
SCC Soft Computer
Palm Harbor, FL
BK050045 SoftDonor 4.3 with SoftScape 1.2.0 10/26/2005
SCC Soft Computer
Clearwater, FL
BK090078 SoftID.Tx Version 1.0 12/03/2009
SCC Soft Computer
Clearwater, FL
BK090017 SoftBank II® Version 25 06/23/2009
SCC Soft Computer
Clearwater, FL
BK080069 SoftDonor® Version 4.5 01/16/2009
SCC Soft Computer
Clearwater, FL
BK080020 SoftBank II v23.2 08/12/2008
SCIMEDX Corp
Denville, NJ
BK960070 Olympus PK-TP System Control Set 06/19/1997
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
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
BK140152 ADVIA Centaur® (SW V4.0 SP4) 06/8/2015
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY
BK140153 ADVIA Centaur® XP (SW v7.1) 06/8/2015
Siemens Healthcare Diagnostics Inc.
Berkeley, CA
BK120013 TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System 03/27/2012
Siemens Healthcare Diagnostics Inc.
Berkeley, CA
BK110007 TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System 03/04/2011
Siemens Healthcare Diagnostics Inc.
Berkeley, CA
BK090077 TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System 12/28/2009
Siemens Healthcare Diagnostics Inc.
Berkeley, CA
BK080073 TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System 01/15/2009
Sienna Partners
Baldwin, MD
BK040066 Greiner VACUETTE No Additive Evacuated Blood Collection Tubes and Serum Clot Activator Blood Collection Tubes 09/10/2004
Sienna Partners
Baldwin, MD
BK040018 VACUETTE EDTA K2 tube
VACUETTE EDTA K3 tube
07/28/2004
Smith & Nephew, Inc
Memphis, TN
BK060004 Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System 05/02/2006
Soft Computer Consultants, Inc
Palm Harbor, FL
BK040048 SoftBank II v23.1 with Database Management System Interface (DMSI) 08/23/2004
Soft Computer Consultants, Inc
Palm Harbor, FL
BK040028 SoftBank II version 23 with SoftScape 05/07/2004
Soft Computer Consultants, Inc
Palm Harbor, FL
BK030018 SoftBank II 23 04/17/2003
Soft Computer Consultants, Inc
Palm Harbor, FL
BK020006 SoftDonor 4.1 02/27/2003
Soft Computer Consultants, Inc
Palm Harbor, FL
BK020021 SoftBank II 22 09/11/2002
Soft Computer Consultants, Inc
Palm Harbor, FL
BK000040 Softbank II Version 21.1 04/20/2001
Soft Computer Consultants, Inc
Palm Harbor, FL
BK960033 Softbank II Version 19.1 07/10/1998
Spine Smith Partners, LLC
Austin, TX
BK090047 Fusionary Graft Delivery System 02/10/2010
Stemco Biomedical, Inc
Durham, NC
BK040075 Aldecount Progenitor Cell Enumeration Kit 01/06/2005
Stemco Biomedical, Inc
Durham, NC
BK030064 Aldecount Progenitor Cell Enumeration Kit 12/31/2003
Sunquest Information Systems, Inc.
Tucson, AZ
BK160005 Sunquest Blood Bank and Blood Donor, version 8.0 03/25/2016
Sunquest Information Systems, Inc.
Tucson, AZ
BK140124 Sunquest Transfusion Manager, version 2.0 06/18/2014
Sunquest Information Systems, Inc.
Tucson, AZ
BK080042 Sunquest Blood Bank Donor 6.4 03/03/2009
Sunquest Information Systems, Inc.
Tucson, AZ
BK990034 FlexiLab Blood Bank and Blood Donor System, version 5.2 11/17/1999
Sunquest Information Systems, Inc.
Tucson, AZ
BK990002 Flexilab Blood Bank and Blood Donor, Version 5.2 08/16/1999
Sunquest Information Systems, Inc.
Tucson, AZ
BK080021 Sunquest Transfusion Manager v1.0 12/03/2008
SynGen, Inc. Sacramento, CA BK120061 SynGenX-1000 07/11/2013
SysLogic, Inc.
Brookfield, WI
BK120067 iTrace for Blood Centers, v 1.0.924.0 5/28/2013
Sysmex America, Inc.
Mundelein, IL
BK080067 Sysmex® XE-2100D 09/28/2009
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK060032 LifeTec Elite 1.0 08/21/2006
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK040026 LifeTec Donor Verification and Collection System (DOVAC) 1.00 10/21/2004
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK990003 LifeTec, Version 2.20 07/30/1999
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK960034 LifeTec Community Blood Center System Revision 2.10 07/28/1998
Back to Alphabetical Index
T
Talisman Ltd
Vienna, VA
BK070020 Quality Donor System v2.1 07/16/2007
Talisman Ltd
Vienna, VA
BK060031 Talisman Phlebotomy System, Release 1.0 07/27/2006
Talisman Ltd
Vienna, VA
BK040062 Quality Donor System 2004 2.0 10/18/2004
Tepnel Lifecodes Corporation
Stamford, CT
BK090018 LIFECODES Evolution Software, version 1.0 06/04/2009
Tepnel Lifecodes Corporation
Stamford, CT
BK050003 LIFECODES HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB Typing Kits for use with Luminex 100 07/18/2005
Terumo BCT, Inc
Lakewood, CO
BK150321 Trima Accel System 10/16/2015
Terumo BCT, Inc.
Lakewood, CO
BK150228 Vista Information System Version 4.0 09/22/2015
Terumo BCT, Inc.
Lakewood, CO
BK150269 Trima Accel® System 08/06/2015
Terumo BCT, Inc.
Lakewood, Colorado
BK150251 Spectra Optia® Apheresis System 07/17/2015
Terumo BCT, Inc
Lakewood, Colorado
BK140191 Spectra Optia® Apheresis System 03/09/2015
Terumo BCT, Inc
Lakewood, CO
BK140180 Trima Accel System Mobile Pro Package 11/05/2014
Terumo BCT, Inc
Lakewood, CO
BK140158 Trima Accel System 6.4 08/29/2014
Terumo BCT, Inc
Lakewood, CO
BK140104 Vista Information System, Version 3.2 04/01/2014
Terumo BCT, Inc.
Lakewood, CO
BK130080 Trima Accel® System, Version 6.2 03/19/2014
Terumo BCT, Inc.
Lakewood, CO
BK130065 Spectra Optia® Apheresis System 01/16/2014
Terumo BCT, Inc.
Lakewood, CO
BK130031 Spectra Optia® Apheresis System 07/25/2013
Terumo BCT, Inc.
Lakewood, CO
BK120076 Spectra Optia® Apheresis System 02/26/2013
Terumo BCT, Inc.
Lakewood, CO
BK120040 Trima Accel® System 10/4/2012
Terumo BCT, Inc.
Lakewood, CO
BK120012 Spectra Optia® Apheresis System 07/09/2012
Terumo BCT, Inc.
Lakewood, CO
BK120017 Trima Accel Automated Blood Component Collection System 05/31/2012
Terumo BCT, Inc.
Lakewood, CO
BK110068 Trima Accel® Automated Blood Component Collection System 03/23/2012
Terumo Medical Corp
Lakewood, CO
BK110071 TSCD®II Sterile Tubing Welder with or without Trucise® Total System 09/12/2012
Terumo Medical Corp
Elkton, MD
BK040082 TSCD-II Terumo Sterile Tubing Welder 04/05/2005
Terumo Medical Corp
Elkton, MD
BK020033 Imugard III-PL Leukocyte reduction filter 05/22/2003
Terumo Medical Corp
Elkton, MD
BK970008 Terumo Sterile Tubing Welder SC-201A (TSCD) 05/28/1998
Terumo Medical Corp
Elkton, MD
BK970011 Terumo Phlebotomy Needle Cap Holder 06/19/1997
Texas BioGene, Inc
Richardson, TX
BK080039 Morgan™ HLA SSP ABDRDQ Typing Kit 04/22/2009
Texas BioGene, Inc
Richardson, TX
BK060060 Morgan HLA SSP ABDR Typing Kit 03/22/2007
Thermogenesis
Rancho Cordova, CA
BK100066 Res-Q 60 PRP Device 05/27/2011
Thermogenesis
Rancho Cordova, CA
BK960072 CryoSeal System 02/12/1999
Thermogenesis
Rancho Cordova, CA
BK070006 AXP AutoXpress Platform 10/05/2007
The Surgical Company International
Netherlands
BK070055 Fluido Accessories: Fluido Air Guard, Fluido Compressor, Fluido IV-Pole and Fluido Pressure Chamber 01/15/2008
The Surgical Company International
Netherlands
BK050058 Fluido Blood and Fluid Warmer System 05/05/2006
Timestrip UK Limited
United Kingdom
BK150289 Timestrip® Blood Temp 10 (BT10) 12/14/2015
Typenex Medical, LLC BK150351 Typesafe® 2.0 Segment Piercing Device 12/28/2015
Back to Alphabetical Index
U
Utah Medical Products, Inc
Midvale, UT
BK970026 Umbilicup 01/28/1998
Back to Alphabetical Index
V
VEEGEE Scientific
Kirkland, WA
BK010043 Atago SP-D2 Refractometer 01/02/2002
Verax Biomedical Incorporated
Marlborough, MA
BK140201 Platelet PGD® Test System 05/13/2015
Verax Biomedical Inc
Worcester, MA
BK110014 Platelet PGD® Test System 09/08/2011
Verax Biomedical Inc
Worcester, MA
BK070044 Platelet PGD Test System 09/17/2007
Verax Biomedical Inc
Worcester, MA
BK090028 Platelet PGD Test System 11/10/2009
Visible Genetics, Inc
Canada
BK000038 TRUEGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System 09/26/2001
Back to Alphabetical Index
W
Wyndgate Technologies
El Dorado Hills, CA
BK090033 ElDorado Donor Doc 10/28/2009
Wyndgate Technologies
El Dorado Hills, CA
BK090063 Test Result Interface for ElDorado Donor 11/20/2009
Wyndgate Technologies
El Dorado Hills, CA
BK070064 ElDorado Donor 1.0.0 02/13/2008
Wyndgate Technologies
El Dorado Hills, CA
BK070010 ElDorado Donor Doc 1.0.0 05/23/2007
Wyndgate Technologies
Rancho Cordova, CA
BK980023 SafeTrace TX, version 1.0 01/29/1999
Wyndgate Technologies
Rancho Cordova, CA
BK100002 Component Manufacturing Interface for ElDorado Donor 02/01/2010
Wyndgate Technologies
Rancho Cordova, CA
BK950059 Safe Trace Version 1.0 04/14/1997
Back to Alphabetical Index
Z
ZLB Behring AG
Switzerland
BK050078 System for Plasma Identification (SPI) 2.0.0 12/22/2005
ZLB Bioplasma AG
Switzerland
BK020020 System for Plasma Identification (SPI) 1.0 10/30/2002
Back to Alphabetical Index

 

Contact FDA

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Silver Spring, MD 20993-0002

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