Vaccines, Blood & Biologics

Cleared 510(k) Submissions with Supporting Documents

alThis 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 

Applicant510K NumberProductDate
A
Abbott Laboratories
Abbott Park, IL
BK950048Abbott Apheresis Tracking System (AARTS) Version 1.006/24/1998
Abbott Laboratories
Abbott Park, IL
BK950052Abbott DMS II Version 1.508/12/1998
Abbott Laboratories
Abbott Park, IL
BK950032Abbott DMS Version 3.0.208/18/1998
Abbott Laboratories
Abbott Park, IL
BK010036Abbott Prism Retest07/17/2002
AbSorber AB
SWEDEN
BK070011XM-ONE Transplantation Cross Match07/29/2008
AcroMetrix Corp
Benicia, CA
BK060064VeriSure Pro HBV DNA External Quality Control02/08/2007
AcroMetrix Corp
Benicia, CA
BK050061VeriSure 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
BK960002ACT Buoyant Density Solution08/12/1996
ADAC HealthCare Information System
Houston, TX
BK960027LabCare Blood Bank II Version 13.308/12/1998
Alba Bioscience Ltd
United Kingdom
BK140144ALBAzyme™ Papain Solution kit09/17/2014
Alba Bioscience
United Kingdom
BK100005ALBAcyte® IgG Sensitized Red Blood Cells08/26/2010
Alba Bioscience
United Kingdom
BK090030ALBAcheck® - BGS Simulated Whole Blood Controls06/14/2010
Alba Bioscience
United Kingdom
BK080051FETALSCREEN™ II04/08/2009
Alba Bioscience
United Kingdom
BK080027ALBAcheck - BGS Reagent Control for Anti-D 07/29/2008
Alba Bioscience
United Kingdom
BK070033AlbaQ-Chek Simulated Whole Blood Controls07/27/2007
Alpha Scientific Corp
Southeastern, PA
BK940054SEG-SAFE03/15/1995
Alpha Therapeutic Corp
City of Industry, CA
BK950044Transfer Device10/18/1995
American Blood Resources Association
Annapolis, MD
BK010012National Donor Deferral Registry (NDDR) 1.008/30/2001
American Blood Resources Association
Annapolis, MD
BK960030National Donor Deferral Registry03/20/1997
American National Red Cross Gaithersburg, MDBK120042DailyChek QC Kit10/6/2012
American Red Cross
Washington, DC
BK960040National Biomedical Computer System, Version 1.102/28/1997
American Red Cross Blood Services
Arlington, VA
BK020032NGTL Automation System (NAS) 5.2.003/20/2003
American Red Cross
Gaithersburg, MD
BK090021American Red Cross Control Cells06/24/2009
Applied Biosystems / Celera Diagnostics
Alameda, CA
BK030005ViroSeq HIV-1 Genotyping System with the 3100 Genetic Analyzer01/29/2003
Applied Science, Inc
Grass Valley, CA
BK010031Hemoflow Model 400 with Data Scanner01/23/2002
Arlington Scientific, Inc
Springville, UT
BK020031ASI TPHA Test01/30/2003
Arthrex Incorporated
Naples, FL
BK070069Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System12/12/2008
Back to Alphabetical Index
B
Barkey GmbH & Co. KG
Germany
BK100063plasmatherm11/17/2011
Baxter Healthcare Corp
Glendale, CA
BK020002Serology SQL LIMS 1.008/07/2002
Baxter Healthcare Corp
McGaw Park, IL
BK060061ALYX Component Collection System: ALYX 2RBC-NLR Kit 02/09/2007
Baxter Healthcare Corp
McGaw Park, IL
BK050038AMICUS Separator System11/03/2005
Baxter Healthcare Corp
Round Lake, IL
BK040084ALYX Component Collection System03/15/2005
Baxter Healthcare Corp - Transfusion Therapies Division
Round Lake, IL
BK040059Amicus Separator System09/24/2004
Baxter Healthcare Corp
Round Lake, IL
BK020059ALYX Component Collection System01/23/2003
Baxter Healthcare Corp
Round Lake, IL
BK020056ALYX System12/20/2002
Baxter Healthcare Corp
Round Lake, IL
BK020008LeukoConnect12/16/2002
Baxter Healthcare Corp
Round Lake, IL
BK010033Cygnet System08/27/2002
Baxter Healthcare Corp
Round Lake, IL
BK000039Amicus Separator, Concurrent Collection of Red Blood Cells08/26/2002
Baxter Healthcare Corp
Round Lake, IL
BK000047Amicus Separator, Mononuclear Cell Collection07/31/2002
Baxter Healthcare Corp
Round Lake, IL
BK990009Fenwal Amicus Separator Collection of Three Platelet Products03/03/2000
Baxter Healthcare Corp
Round Lake, IL
BK980041Sepacell Pre-Storage Leukocyte Set for Red Cells07/16/1999
Baxter Healthcare Corp
Round Lake, IL
BK940009Optipress Automated Blood Component Extractor05/18/1994
Baxter Healthcare Corp
Round Lake, IL
BK920003Fenwal Needle/Tube Sampling Protector and Needle Safety Cover03/12/1992
Bayer Corp
Berkeley, CA
BK960051Plasma Procurement Information System Version 2.008/07/1998
Bayer Corp
Berkeley, CA
BK990024Plasma Procurement Information System (PPIS), version 3.011/03/1999
Bayer Corp
Berkeley, CA
BK990037Plasma Procurement Information System (PPIS), version 4.011/17/1999
BBI Diagnostics
West Bridgewater, MA
BK060030ACCURUN 804 Nucleic Acid Negative Quality Control (HIV, HCV, HBV, WNV)08/18/2006
BBI Diagnostics
West Bridgewater, MA
BK060022ACCURUN 365 West Nile Virus RNA Positive Quality Control06/12/2006
BBK Technology LLC
Phoenix, AZ
BK100037RC-AID, version 2.009/13/2010
BD Biosciences
San Jose, CA
BK110037BD™ Stem Cell Enumeration Kit10/19/2011
BD Biosciences
San Jose, CA
BK050073BD HLA-B27 System02/16/2006
BD Biosciences
San Jose, CA
BK050062BD HLA-B27 kit 10/27/2005
BD Biosciences
San Jose, CA
BK030027BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit07/10/2003
Beckman Coulter, Inc
Miami, FL
BK040055stemCXP System for the FC 500 with CXP Software09/16/2004
Beckman Coulter, Inc
Miami, FL
BK040032Stem-Kit Reagents05/05/2004
Beckman Coulter, Inc
Miami, FL
BK020063LeukoSure Enumeration Kit with Leuko-Trol RBC Control Cells and Leuko Trol Platelet Control Cells02/03/2003
Beckman Coulter, Inc
Miami, FL
BK010044stemONE System for EPICS XL/XL-MCL Flow Cytometry Systems05/20/2002
Becton, Dickinson & Company
Franklin Lakes, NJ
BK060046Bd.id Patient Identification System for Transfusion Management V7.00 02/13/2007
Becton, Dickinson & Company
Franklin Lakes, NJ
BK050036BD 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
BK040030BD Vacutainer Plus Plastic Serum Tubes with Clot Activator05/05/2004
Becton Dickinson Vacutainer Systems
Franklin Lakes, NJ
BK980011VACUTAINER Brand PLUS (Plastic) Blood Collection Tube with EDTA Anticoagulant 06/07/1999
BioArray Solutions, Ltd.
Warren, NJ 
BK130051BioArray™ Array Imaging System (AIS) 400C05/21/2014
BioArray Solutions, Ltd.
Warren, NJ
BK130050PreciseType HEA BeadCheck Kit05/21/2014
BioErgonomics, Inc
St. Paul, MN
BK000046FluoroTrol Control Kits04/02/2001
Biofortuna Ltd.
Grayslake, IL
BK130028SSPGo HLA Typing Kit12/19/2013
BioLife Plasma Services, LP
Deerfield, IL
BK120069Automated Plasma Dispositioning System (APDS) v1.005/31/2013
BioLife Plasma Services, LP
Deerfield, IL
BK120064Donor Information System (DIS) v6.012/19/2012
BioLife Plasma Services, LP
Deerfield, IL
BK100021Donor Information System (DIS) Version 5.006/18/2010
BioLife Plasma Services, LP
Deerfield, IL
BK090001Donor Information System (DIS) version 4.008/18/2009
BioLife Plasma Services LP
Deerfield, IL
BK080016Donor Information System v3.307/02/2008
BioLife Plasma Services LP
Deerfield, IL
BK060017Donor Information System (DIS) 3.205/09/2006
BioLife Plasma Services LP
Deerfield, IL
BK050029Donor Information System (DIS) 3.107/07/2005
Biomat USA, Inc.
City of Industry, CA
BK090082System for Plasma Identification (SPI), Version 2.0.010/01/2010
BioMerieux, Inc
Durham, NC
BK050037BacT/ALERT BPA Culture Bottle12/27/2005
BioMerieux, Inc
Durham, NC
BK050043BacT/ALERT BPN Culture Bottle 12/27/2005
BioMerieux, Inc
Durham, NC
BK030076BacT/ALERT BPA Culture Bottles03/08/2004
BioMerieux, Inc
Durham, NC
BK030075BacT/ALERT BPN Culture Bottles03/08/2004
BioMerieux, Inc
Durham, NC
BK030034BacT/ALERT BPN Culture Bottle07/18/2003
BioMerieux, Inc
Durham, NC
BK020022BacT/ALERT SN Culture Bottle10/10/2002
BioMerieux, Inc
Durham, NC
BK020023BacT/ALERT SA Culture Bottle10/10/2002
BioMerieux, Inc
Durham, NC
BK000042BacT/ALERT Culture Bottles02/15/2002
Biomet Biologics, Incorporated
Warsaw, IN
BK110040Clotalyst® 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
BK100027BioCUE™ Platelet Concentration Kit
BioCUE™ Mini Platelet Concentration Kit
05/26/2010
Biomet Biologics, Incorporated
Warsaw, IN
BK090008GPS® II Platelet Concentration System12/18/2009
Biomet Biologics, Incorporated
Warsaw, IN
BK080004Clotalyst 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
BK070036Vortech® Concentration System11/21/2007
Biomet,Inc.
Warsaw, IN
BK070026GPS III Mini Platelet Concentrate Separation Kit with ACD-A06/20/2007
Biomet,Inc.
Warsaw, IN
BK070003GPS II Platelet Concentration Separation Kit with ACD-A02/22/2007
Biomet,Inc.
Warsaw, IN
BK050016GPS II Platelet Concentrate Separation Kit w/ Plasma Concentrator Accesory07/20/2005
Biomet,Inc.
Warsaw, IN
BK040036GPS II Platelet Concentrate Separation Kit06/24/2004
Biometric Imaging, Inc
Mountain View, CA
BK970015CEQer RBC Assay09/18/1998
Biometric Imaging, Inc
Mountain View, CA
BK970016CEQer PRP Assay09/18/1998
Biometric Imaging, Inc
Mountain View, CA
BK970018STELLer CD34 Assay08/18/1998
Bio-Rad Medical Diagnostics GmbH
Redmond, WA
BK130070MLB 2 (10 x 10 mL)11/27/2013
Biosafe SA
Switzerland
BK110022Sepax Cell Separation System and Single-Use Kits, Sepax 2 S-10010/28/2011
Biosafe SA
Alexandria, VA
BK060036Sepax Cell Separation System and single use kits01/03/2007
Biotechnology Institute SL
Spain
BK090069Endoret Kit01/29/2010
Biotest AG
Germany
BK060066TANGO Automated Blood Bank Analyzer System, Version 3.0 Service Pack 401/17/2007
Biotest Medical Diagnostics GmbH
Germany
BK080013Alsever’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
BK080012Seraclone Control ABO+Rh; Coombscell-E; MLB2 07/23/2008
Biotest Diagnostics Corp
Denville, NJ
BK960061Biotest DQB-ELPHA08/04/1997
Biotest Diagnostics Corp
Denville, NJ
BK960086Biotest High Resolution Supplementary Kit07/03/1997
Blackhawk BioSystems, Inc
San Ramon CA
BK060052AmpliTrol III 11/07/2006
Blood Bank Computer Systems, Inc
Auburn, WA
BK140130ABO QuickPass, version 1.0.010/10/2014
Blood Bank Computer Systems, Inc
Auburn, WA
BK140142BBCS Primary Application, version 5.4.310/10/2014
Blood Bank Computer Systems, Inc
Auburn, WA
BK120028BBCS 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
BK960044Blood Bank Control System Version 4.0/4.1/4.2/4.310/15/1997
Blood Bank Computer Systems, Inc
Auburn, WA
BK090081BBCS Hospital Interface Application (BBCSH), H 1.0.012/23/2009
Blood Bank Computer Systems, Inc
Auburn, WA
BK050013BBCS Mobile Application 5.0M06/01/2005
Blood Bank Computer Systems, Inc
Auburn, WA
BK040087BBCS Lab Interface Application (BBCS Lab) 5.0L02/15/2005
Blood Bank Computer Systems, Inc
Auburn, WA
BK040056Blood Bank Control System (BBCS) 5.010/22/2004
Boekel Scientific
Feasterville, PA 
BK100051Boekel Scientific Plasma Thawer, Model 30100004/22/2011
Boston Biomedica, Inc
West Bridgewater, MA
BK040016ACCURUN 305 HCV RNA Positive Quality Control12/17/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK040067ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV)11/19/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK040064ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 15010/29/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK040006ACCURUN 315 HIV-1 RNA Positive Control10/12/2004
Boston Biomedica, Inc
West Bridgewater, MA
BK990032Accurun 106 HIV-1 Antigen01/20/2000
BTI Biotechnology Institute S.L.
Spain
BK130049BTI ENDORET® Kit for Platelet and Plasma Separator01/16/2014
Back to Alphabetical Index
C
Calimex USA Corporation
Alameda, CA
BK120035Picture - ID Version 2.012/17/2012
Calimex USA Corporation
Alameda, CA
BK110070eOrders, Version 102/17/2012
Calimex USA Corporation
Alameda, CA
BK090054Picture-ID01/11/2010
Care Fusion, Inc.
McLean, VA
BK040002wBlood Care 1.011/10/2004
CaridianBCT, Inc.
Lakewood, CO
BK110051Trima Accel Automated Blood Component Collection System12/20/2011
CaridianBCT, Inc.
Lakewood, CO
BK080029Trima Accel®Automated Blood Component Collection System05/18/2010
CaridianBCT, Inc.
Lakewood, CO
BK090003Trima Accel®System01/29/2010
CaridianBCT, Inc.
Lakewood, CO
BK080058Trima Accel® Automated Blood Component Collection System11/25/2008
CaridianBCT, Inc.
Lakewood, CO
BK080043Atreus Whole Blood Processing System09/29/2008
CaridianBCT, Inc.
Lakewood, CO
BK080035Trima Accel Automated Blood Component Collection System, COBE Spectra Apheresis System08/29/2008
CaridianBCT, Inc.
Lakewood, CO
BK100032Trima Accel® Automated Blood Component Collection System05/20/2010
Carter BloodCare
Bedford, TX
BK990015LifeTrak / Distribution, version 2.0310/22/1999
Carter BloodCare
Bedford, TX
BK990027LifeTrak / Donor, version 2.0312/15/1999
Cascade Medical Enterprises, LLC
Wayne, NJ
BK120009FIBRINET® Autologous Platelet System- BK12000908/01/2012
Cascade Medical Enterprises, LLC
Wayne, NJ
BK120008FIBRINET® Autologous Platelet System- BK12000808/01/2012
Cascade Medical Enterprises, LLC
Wayne, NJ
BK020051Cascade Medical Fibrinet, Autologous Platelet System12/20/2002
Celera Diagnostics
Alameda, CA
BK030033ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer06/11/2003
Celera Diagnostics/Applied Biosystems, Inc
Alameda, CA
BK010024ViroSeq HIV-1 Genotyping System12/10/2002
Cellmedix Holdings, LLC
Watertown, MA
BK130079Centrepid TM PC Kit07/31/2014
Cerner Corporation
Kansas City, MO
BK060037Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.305/24/2007
Cerner Corporation
Kansas City, MO
BK030028Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.0108/19/2003
Cerner Corporation
Kansas City, MO
BK950051PathNet Blood Bank Center Version 30607/16/1997
Cerner Corporation
Kansas City, MO
BK950053PathNet Blood Bank Transfusion Version 30607/16/1997
Cerner Corporation
Kansas City, MO
BK950055PathNet Blood Bank Donor Version 30607/16/1997
Cerner Corporation
Kansas City, MO
BK960024PathNet Worksystems Blood Bank Transfusion Version 30607/16/1997
Cerner Corporation
Kansas City, MO
BK990007HNA Millennium PathNet Blood Bank Transfusion11/02/1999
Charter Medical, Ltd
Winston-Salem, NC
BK100049Cell-Freeze® Cryogenic Storage12/07/2010
Charter Medical, Ltd
Winston-Salem, NC
BK050021Charter Medical Transfer Set07/22/2005
Charter Medical, Ltd
Winston-Salem, NC
BK060042Cell Freeze Liquid Nitrogen Freezing Container10/03/2008
Chiron Corporation
Emeryville, CA
BK060005Chiron Procleix NAT Tracker 3.003/01/2006
Chiron Corporation
Emeryville, CA
BK050004Procleix Optiva RAS 04/08/2005
Circle Biologic, LLC
Minneapolis, MN
BK100014Autologous Platelet Concentrator (APC)™ System07/09/2010
COBE Cardiovascular, Inc
Arvada, CO
BK050033COBE Angel Whole Blood Separation System 08/22/2005
COBE BCT
Lakewood, CO
BK990025COBE Trima04/07/2000
COBE BCT
Lakewood, CO
BK970005Focussed System10/13/1998
Community Bio-Resources, Inc
Hoover, AL
BK970007Donor Information System, Version 1.004/09/1997
Community Blood Centers of South Florida
Lauderhill, FL 33313
BK110048Regulated Software Application (RSA)01/12/2012
Community Blood Center of Greater Kansas City
Kansas City, MO
BK960060CBC Blood System Version 1.211/20/1997
Computer Programs and Systems, Inc.
Mobile, AL
BK130003Blood Administration, version 190004/30/2014
CSL Behring AG
Switzerland
BK110023System for Plasma Identification (SPI), version 3.1.006/08/2011
Cytomedix, Incorporated
Gaithersburg, MD
BK110046Angel® Concentrated Platelet Rich Plasma (cPRP) System11/07/2012
Cytomedix, Inc
Rockville, MD
BK060007AutoloGel System09/20/2007
CytoTherm
Trenton, NJ
BK080019CytoTherm Plasma Thawing System07/16/2008
CytoTherm LP
Trenton, NJ
BK060027CytoTherm Plasma Thawing System08/01/2006
Back to Alphabetical Index
D
Data Innovations, Inc
South Burlington, VT
BK120051Instrument Manager v8.1210/17/2012
Data Innovations, Inc
South Burlington, VT
BK100046Instrument Manager v8.1008/12/2010
Data Innovations, Inc
South Burlington, VT
BK060053Instrument Manager 8.05.01.10 01/05/2007
Data Innovations, Inc.
South Burlington, VT
BK020057imExpress 7.2.507/29/2003
DENCO, Inc
Wilmington, DE
BK000022Total Containment Device04/18/2000
DENCO, Inc
Wilmington, DE
BK990041Total Containment Device TCD12/21/1999
Department of Defense
Falls Church, VA
BK070035Defense Blood Standard System (DBSS) 10.0.005/22/2008
Department of Defense
Falls Church, VA
BK960004Defense Blood Standard System Versions 1.00/1.0308/01/1997
Department of Defense
Falls Church, VA
BK980031Defense Blood Standard System Version 3.0008/31/1998
Department of Veterans Affairs
Hines, IL
BK060043VistA Blood Establishment Computer Software (VBECS) 1.010/19/2006
Department of Veterans Affairs
Hines, IL
BK970021Vista Blood Bank, Version 5.204/23/1999
Diagnostic Grifols S.A.
Spain
BK140101DG Reader05/21/2014
Diagnostic Grifols S.A.
Spain
BK130067Erytra®01/17/2014
Diagnostic Grifols S.A.
Spain
BK130025WADiana® Compact08/30/2013
Diagnostic Grifols S.A.
Spain
BK120046DG THERM07/25/2012
Diagnostic Grifols S.A.
Spain
BK120045DG SPIN07/24/2012
Diagnostic Grifols S.A.
Spain
BK120044Grifols Diluent07/24/2012
Diagnostic Grifols S.A.
Spain
BK120043DG Gel 8 Neutral07/20/2012
Diaspect Medical GMBH
Richmond, VA
BK120052DiaSpect Control HBT (-L, -M. -H)11/04/2012
DiaSpect Medical GmbH
C/O Regulatory Resources, Inc.
Richmond, VA
BK110036DiaSpect Hemoglobin T and DiaSpect Hemoglobin Cuvettes11/01/2011
Digi-Trax Corp
Buffalo Grove, IL
BK010049Donor-ID 2.204/26/2002
Digi-Trax Corp
Buffalo Grove, IL
BK000020Digi-Trax Donor-ID 2.004/20/2000
Digi-Trax Corp
Buffalo Grove, IL
BK970013DONOR-ID, version 1.002/27/1998
DSM Biomedical
Exton, PA
BK130053DSM Biomedical PRP Device03/25/2014
Duley Hopkins and Associates
Chattanooga, TN
BK090079Blood Bank Information Management System (BBIMS) v2.05.0101/13/2010
Duley Hopkins and Associates
Chattanooga, TN
BK070065Blood Bank Information Management System (BBIMS)04/25/2008
Dynal Biotech Ltd
United Kingdom
BK050012Dynal 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
BK030056Dynal Reli SSO HLA-A Typing Kit01/29/2004
Dynal Biotech Ltd
United Kingdom
BK030057Dynal Reli SSO HLA-B Typing Kit01/29/2004
Dynal Biotech Ltd
United Kingdom
BK030058Dynal Reli SSO HLA-Cw Typing Kit01/29/2004
Dynal Biotech Ltd
United Kingdom
BK030059Dynal Reli SSO HLA-DQB1 Typing Kit01/29/2004
Dynal Biotech Ltd
United Kingdom
BK030060Dynal Reli SSO HLA-DRB Typing System01/29/2004
Dynamic Healthcare Technologies, Inc
Maitland, FL
BK960041Transfusion Service Manager, Version 4.1.612/16/1997
Back to Alphabetical Index
E
Eclipsys Corporation
Malvern, PA
BK090044Sunrise Blood Bank version 2.0 SP211/13/2009
Epic Systems Corporation
Verona, WI
BK130037Blood Product Administration Module, version 0.903/06/2014
Estar Technologies Ltd.
New York, NY
BK110035TropoCells Autologous Platelet Preparation Kit Regulation03/28/2012
Ethicon, Inc.
Somerville, NJ
BK140093EvicelTMApplication Device09/03/2014
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F
Fenwal Inc.
Lake Zurich, IL
BK130030Alyx Component Collection System11/01/2013
Fenwal Inc.
Lake Zurich, IL
BK130004ALYX Component Collection System09/11/2013
Fenwal Inc.
Lake Zurich, IL
BK120082AMICUS Apheresis Kits
AMICUS Separator System
01/08/2013
Fenwal Inc.
Lake Zurich, IL
BK120047Autopheresis-C Plasampheresis System Plasmacell-C Set
 
12/18/2012
Fenwal Inc.
Lake Zurich, IL
BK120041AMICUS Separator System;
ALYX Component System
09/25/2012
Fenwal Inc.
Lake Zurich, IL
BK120018AMICUS Separator System
AMICUS Apheresis Kits
07/20/2012
Fenwal Inc.
Lake Zurich, IL
BK110072Aurora Plasmapheresis System;
Plasmacell-C Disposable Set
03/29/2012
Fenwal Inc.
Lake Zurich, IL
BK110066Product Sample Pack02/27/2012
Fenwal Inc.
Lake Zurich, IL
BK110030AMICUS Separator System with Software Version 4.312/23/2011
Fenwal Inc.
Lake Zurich, IL
BK110025Fenwal DXT Relay, Software Version 2.008/22/2011
Fenwal Inc.
Lake Zurich, IL
BK100056ALYX® Component Collection System12/07/2010
Fenwal Inc.
Lake Zurich, IL
BK100050Autopheresis-C™ Plasmapheresis System11/16/2010
Fenwal Inc.
Lake Zurich, IL
BK100041Autopheresis-C™ Plasmapheresis System08/05/2010
Fenwal Inc.
Lake Zurich, IL
BK100044AMICUS® Separator System07/30/2010
Fenwal Inc.
Lake Zurich, IL
BK090065AMICUS® SeparatorSystem01/27/2010
Fenwal Inc.
Lake Zurich, IL
BK090058AMICUS® SeparatorSystem02/18/2010
Fenwal Inc.
Lake Zurich, IL
BK090031Bone Marrow Collection/Transfusion Kit07/23/2009
Fenwal Inc.
Lake Zurich, IL
BK080053ALYX Component Collection System12/22/2008
Fenwal Inc.
Lake Zurich, IL
BK080048AMICUS® Separator: Software 3.1 with EDI Export10/02/2008
Fenwal Inc.
Lake Zurich, IL
BK080018Amicus Separator System08/26/2008
Fenwal Inc.
Lake Zurich, IL
BK080033PLASMALINK08/22/2008
Fenwal Inc.
Lake Zurich, IL
BK080024ALYX Component Collection System06/24/2008
Fifth Dimension Information Systems
Canada
BK050060E-Interview (eQue) 1.0.0 05/24/2006
Fifth Dimension Information Systems
Canada
BK040040LOGIC 2.010/06/2004
Fifth Dimension Information Systems
Canada
BK020058LOGIC 1.002/03/2003
Fifth Dimension Information Systems
Canada
BK000026P2K Plasma Center Module 2000 Version 1.006/22/2000
Fifth Dimension Information Systems
CANADA
BK990022Donor Management System, version 1.0.009/10/1999
Fifth Dimension Information Systems
Canada
BK980025Plasma Center Module, Version 1.005/18/1999
Fresenius Hemocare Inc
Lexington, MA
BK040076Compodock12/17/2004
Fresenius Hemocare Inc
Lexington, MA
BK040005Fresenius Compoguard & Donationmaster NT03/26/2004
Fresenius Hemocare Inc
Redmond, WA
BK030022Fresenius Compomat G4 & Compomaster NT07/11/2003
Fresenius Kabi, LLC.
Schaumburg, IL
BK110012CompoMat G5 and CompoMaster Net G5 System08/02/2012
Fujirebio Diagnostics, Inc
Malvern, PA
BK070030Olympus PK CMV-PA Test System and Controls for the Olympus PK7300 Automated Blood Bank Analyzer 09/20/2007
Fujirebio Diagnostics, Inc
Malvern, PA
BK060062Olympus PK TP Reagent System06/25/2007
Fujirebio Diagnostics, Inc
Malvern, PA
BK030007Olympus PK TP System02/21/2003
Back to Alphabetical Index
G
Gambro BCT, Inc
Lakewood, CO
BK080010The Atreus Whole Blood Processing System06/27/2008
Gambro BCT, Inc
Lakewood, CO
BK070066Vista Information System, Version 3.0 with Medical Review Module12/13/2007
Gambro BCT, Inc
Lakewood, CO
BK040086COBE Spectra Apheresis System & Trima Automated Blood Component Collection System03/15/2005
Gambro BCT, Inc
Lakewood, CO
BK040069Trima Automated Blood Component Collection System - Blood Component Sampling Accessary10/28/2004
Gambro BCT, Inc
Lakewood, CO
BK010037Platelet collection sets for the COBE Spectra Apheresis System and the Trima Automated Blood Component Collection System09/24/2003
Gambro BCT, Inc
Lakewood, CO
BK030021Vista Information System 2.105/01/2003
Gambro BCT, Inc
Lakewood, CO
BK020041COBE Spectra Apheresis System/Blood component disposable collection sets for apheresis04/23/2003
Gambro BCT, Inc
Lakewood, CO
BK010050Trima Automated Blood Collection System09/18/2002
Gambro BCT, Inc
Lakewood, CO
BK010046Trima Automated Blood Collection System (Single Stage)09/18/2002
Gambro BCT, Inc
Lakewood, CO
BK020015Vista Information System, Independent Solution07/15/2002
Gambro BCT, Inc
Lakewood, CO
BK010006Trima Automated Blood Component Collection System02/27/2002
Gaymar Industries, Inc
Washington, DC
BK060050Medi-Temp III, Model FW600 Blood/Fluid Warmer11/07/2006
GE Medical Information Technologies
Barrington, IL
BK050018Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 06/13/2005
Genetic Testing Institute
Brookfield, WI
BK960059PAKAUTO Platelet Antibody Screening Kit10/22/1998
Genetic Testing Institute
Brookfield, WI
BK000031GTI-MACE (Modified Capture ELISA)01/29/2001
Gen-Probe, Inc
San Diego, CA
BK060021Procleix TIGRIS System for use with the Procleix WNV Assay02/20/2007
Gen-Probe GTI Diagnostics
Waukesha, WI
BK110011LIFECODES Class II ID v206/04/2012
Gen-Probe Transplant Diagnostics, Inc.
Stamford, CT
BK110002LIFECODES 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
BK120063LIFECODES HLA-C eRES Typing Kit for use with Luminex11/21/2012
Greiner Bio-One North America, Inc.
Monroe, NC
BK050026Greiner Vacuette No Additive Tubes07/07/2005
Greiner Bio-One North America, Inc.
Monroe, NC
BK050028Greiner Vacuette Clot Activator Tube 07/07/2005
Greiner Bio-One GmbH
Westmont, IL
BK030032Greiner Vacuette EDTA K2 Evacuated Blood Collection Tube07/18/2003
Greiner Bio-One GmbH
Westmont, IL
BK030001Greiner Vacuette EDTA K3 Tube02/26/2003
GTI, INC
Waukesha, WI
BK070045Donor Screen HLA Class I and Class II07/30/2008
GTI, INC
Waukesha, WI
BK060038MICROAMS07/28/2006
GTI, INC
Waukesha, WI
BK050054GranType03/02/2006
GTI, INC
Waukesha, WI
BK050040ThromboType (HPA 1-6, 15) and ThromboType 1 (HPA 1) 01/20/2006
GTI, INC
Waukesha, WI
BK040034Lifecodes LifeScreen: A Luminex 100 Screening Assay for the Detection of IgG Antibodies to HLA Class I and Class II Molecules of Human Origin07/16/2004
GTI, INC
Waukesha, WI
BK040035Lifecodes 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
BK040019Antibody Monitoring System Class 1 and Class II (AMS1 and AMS1+2)07/06/2004
Back to Alphabetical Index
H
Haemonetics Corporation
Braintree, MA
BK130056Haemonetics PCS2 Plasma Collection System08/29/2014
Haemonetics Corporation
Braintree, MA
BK140108MCS+ 8150 System-Wireless08/26/2014
Haemonetics Corp
Braintree, MA
BK130081Cymbal Automated Blood Collection System01/22/2014
Haemonetics Corp
Braintree, MA
BK120065PCS2 Plasma Collection System software revision K.111/26/2012
Haemonetics Corp
Braintree, MA
BK120002LOGIC Version 3.0.004/24/2012
Haemonetics Corp
Braintree, MA
BK110015Nextgen, version 1.0.006/13/2011
Haemonetics Corp
Braintree, MA
BK090083Cymbal Automated Blood Collection System01/27/2010
Haemonetics Corp
Braintree, MA
BK090041Symphony System 3.009/28/2009
Haemonetics Corp
Braintree, MA
BK090004MCS+8150 System - Wireless02/20/2009
Haemonetics Corp
Braintree, MA
BK080038MCS+ 9000 System09/04/2008
Haemonetics Corp
Braintree, MA
BK080025Cymbal Automated Blood Collection System 08/15/2008
Haemonetics Corp
Braintree, MA
BK080001PCS2 Plasma Collection System_Revision K software 05/28/2008
Haemonetics Corporation
Braintree, MA
BK060033Haemonetics PCS 2 Plasma Collection System, Wireless (W) Capable Modification03/27/2008
Haemonetics Corp
Braintree, MA
BK060008Haemonetics ACP 215 Glycerolization/Deglycerolization System 05/23/2006
Haemonetics Corp
Braintree, MA
BK050047MCS+9000, SDP revision E software, 994CF-CPP series disposable sets11/21/2005
Haemonetics Corp
Braintree, MA
BK050006ACP 215 Glycerolization/Deglycerolization System 04/14/2005
Haemonetics Corp
Braintree, MA
BK040077Haemonetics Model 215 Automated Glycerolization/Deglycerolization System12/21/2004
Haemonetics Corp
Braintree, MA
BK040041Haemonetics MCS+8150 Apheresis System07/12/2004
Haemonetics Corp
Braintree, MA
BK040025PCS2 Plasma Collection System06/02/2004
Haemonetics Corp
Braintree, MA
BK040020Haemonetics LN994CF-BA Extended Storage Platelet and Plasma Apheresis Set with Leukocyte Reduction Filter, and 4 mL Sampling System03/29/2004
Haemonetics Corp
Braintree, MA
BK040001Haemonetics 4mL Sampling System02/27/2004
Haemonetics Corp
Braintree, MA
BK030062Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation System12/10/2003
Haemonetics Corp
Braintree, MA
BK030031Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation and Cell Washing System09/10/2003
Haemonetics Corp
Braintree, MA
BK010035MCS+ Mobile Collection System12/20/2002
Haemonetics Corp
Braintree, MA
BK020001Plasma Pooling Bottle II03/29/2002
Haemonetics Corp
Braintree, MA
BK000002Model 215 Automated Glycerlization and Deglycerolization System05/04/2001
Haemonetics Corp
Braintree, MA
BK000048Haemonetics LN832F04/09/2001
Haemonetics Corp
Braintree, MA
BK990033MCS+ LN8150 Red Cell Apheresis Instrument01/20/2000
Haemonetics Corporation Software Solutions
El Dorado Hills, CA
BK140166Cross Donation Check System (CDCS) 1.0.010/10/2014
Haemonetics Corporation Software Solutions
El Dorado Hills, CA
BK140133BloodTrack 4.7.008/29/2014
Haemonetics Software Solutions
El Dorado Hills, CA
BK130082NextGen v2.0.008/08/2014
Haemonetics Software Solutions
El Dorado Hills, CA
BK120084Phlebotomy System 1.0.004/30/2013
Harvest Technologies
Plymouth, MA
BK130068Harvest Technologies PRP Separation System with LP-1003/24/2014
Harvest Technologies
Plymouth, MA
BK120038Harvest PRP Separation System with ACD-A (30 mL)09/25/2012
Harvest Technologies
Plymouth, MA
BK100059Harvest PRP Separation System with ACD-A (30 ml)11/18/2010
Harvest Technologies
Norwell, MA
BK000037Harvest PRP Separation System02/05/2001
Healthcare-ID
Buffalo Grove, IL
BK120030Donor-ID™ Web Version 3.2 integrated with biometric finger identification technology, optional06/25/2012
Healthcare-ID
Buffalo Grove, IL
BK080044Donor-ID Web™, version 3.1.406/10/2009
Healthcare-ID
Buffalo Grove, IL
BK060058Donor-ID 3.0 02/08/2007
Healthcare-ID
Buffalo Grove, IL
BK030049Donor-ID10/31/2003
Healthcare Management Systems, Inc
Nashville, TN
BK090025HMS Blood Administration Module, Release 9.002/23/2010
Healthcare Management Systems, Inc
Nashville, TN
BK050001Monitor Blood Administration Module Release 24.009/28/2005
Helmer Labs, Inc
Noblesville, IN
BK020029UltraCW (with Software version 3.13)10/04/2002
Hemasure, Inc
Marlborough, MA
BK980014HemaSure r|LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells05/27/1999
Hemerus Medical, LLC
Saint Paul, MN
BK080031HEMERUS LEUKOSEP ® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells 09/11/2008
Hemo bioscience, Inc
Durham, NC
BK140161Hemo-QC09/08/2014
Hemo Bioscience
Durham, NC 27713
BK120022C3 Control Cells10/24/2012
HemoCue AB
Sweden
BK060048HemoCue Hb 301 System10/05/2006
HemoCue, Inc
Potomac, MD
BK030067HemoCue Donor Hb Checker System12/19/2003
HemoCue, Inc
Potomac, MD
BK030020Donor Hemoglobin Checker System04/17/2003
HemoCue, Inc
Potomac, MD
BK000043HemoCue Low Hemoglobin Analyzing System04/09/2001
Hemosystem, S.A.
Richmond, VA
BK040031Scansytem Bacterial Detection Device09/23/2004
Back to Alphabetical Index
I
Intra-Lock International
Boca Raton, FL
BK120048Intra-Spin System01/28/2013
Immucor, Inc
Norcross, GA
BK120021TPHA Screen10/24/2012
Immucor, Inc
Norcross, GA
BK120016ImmuLINK, version 2.006/14/2012
Immucor, Inc
Norcross, GA
BK110067FMH RapidScreen05/22/2012
Immucor, Inc
Norcross, GA
BK110050Checkcell
Checkcell (Weak)
DAT Positive Control Cell
10/03/2011
Immucor, Inc
Norcross, GA
BK100033Galileo NeoTM Automated Blood Bank System08/23/2010
Immucor, Inc
Norcross, GA
BK090057Galileo®07/09/2010
Immucor, Inc
Norcross, GA
BK100001Galileo Neo04/29/2010
Immucor, Inc
Norcross, GA
BK080070Galileo® Automated Blood Bank System02/05/2009
Immucor, Inc
Norcross, GA
BK070054Galileo Automated Blood Bank System - Add the Reverse ABO Group Assay 11/30/2007
Immucor, Inc
Norcross, GA
BK070040Galileo Automated Blood Bank System with assays to perform red blood cell phenotying09/28/2007
Immucor, Inc
Norcross, GA
BK070016Galileo Echo Automated Blood Bank System06/14/2007
Immucor, Inc
Norcross, GA
BK070015WB corQC06/14/2007
Immucor, Inc
Norcross, GA
BK070014DAT Positive Control Cell06/14/2007
Immucor, Inc
Norcross, GA
BK070013Monoclonal Control06/14/2007
Immucor, Inc
Norcross, GA
BK060009Galileo Automated Blood Bank System with Capture-S Syphilis Screening04/11/2006
Immucor, Inc
Norcross, GA
BK050050Galileo Automated Blood Bank System Capture-CMV11/14/2005
Immucor, Inc
Norcross, GA
BK040057Check cell (Weak)10/06/2004
Immucor, Inc
Norcross, GA
BK040024Capture-R Select Solid Phase System04/28/2004
Immucor, Inc
Norcross, GA
BK040013Galileo version 1.3.6 SP4/DMS version 1.2604/23/2004
Immucor, Inc
Norcross, GA
BK000024ABS2000, Version 2 software (2.05.00A and 2.0500B)07/03/2001
Immucor, Inc
Norcross, GA
BK960019ABS200006/30/1998
Immucor GTI Diagnostics, Inc.
Waukesha, WI
BK130046LIFECODES® LifeScreen Deluxe (LMX)09/23/2013
Immucor Transplant Diagnostics, Inc.
Stamford, CT
BK130075LIFECODES 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
BK130017BacTx® Bacterial Detection Kit for Platelets08/12/2013
Immunetics, Inc.
Boston, MA
BK110054BacTx® Bacterial Detection Kit for Platelets06/11/2012
Indico, Inc
Canada
BK000008RadTag X-ray03/01/2000
Information Data Management, Inc
Rosemont, IL
BK070031IDM Symphony System 2.0 12/13/2007
Information Data Management, Inc
Rosemont, IL
BK050014IDM Prelude System, Version 1.107/18/2005
Information Data Management, Inc
Rosemont, IL
BK020038Surround System, Version 3.210/08/2002
Information Data Management, Inc
Rosemont, IL
BK010028IDM Surround System 3.008/30/2001
Information Data Management, Inc
Rosemont, IL
BK000016Information Data Management Surround System 2.004/07/2000
Information Data Management, Inc
Rosemont, IL
BK990046Plasma Center Management System (PCMS), Version 2.001/06/2000
Information Data Management, Inc
Rosemont, IL
BK990029Plasma Center Management System (PCMS), Version 1.210/13/1999
Information Data Management, Inc
Rosemont, IL
BK990016Surround System 1.008/27/1999
Information Data Management, Inc
Rosemont, IL
BK980028Plasma Center Management System Version 1.109/04/1998
Information Data Management, Inc
Rosemont, IL
BK980020Plasma Center Management System Version 1.007/31/1998
Information Data Management, Inc
Rosemont, IL
BK950037Components & Distribution Information System08/26/1996
Information Data Management, Inc
Rosemont, IL
BK950045Donor Management Information Systems, vers.1.208/26/1996
Informedics, Inc
Lake Oswego, OR
BK950064Lifeline Blood Bank Management System Release 4.207/01/1998
Infra-Med Technologies, Inc
Dallas, TX
BK990018Hot Shot Fluid Warmer10/13/1999
IntelliDOT Corporation
San Diego, CA
BK080006IntelliDOT Blood Product Administration06/13/2008
Invitrogen Corp
Brown Deer, WI
BK070038AllSet Gold SSP09/26/2007
ITL Corporation, Ltd
Australia
BK980008Bloodpack Needle Protector (BNP)04/07/1998
IT Synergistics, LLC
Flowood, MS
BK140091DoVac Elite v2.004/09/2014
IT Synergistics, LLC
Flowood, MS
BK110064DoVac Elite v1.009/06/2012
Back to Alphabetical Index
K
Kaylight Corporation
Irvine, CA
BK080057MyCells Autologous Platelet Preparation Kit09/24/2009
Korchek Technologies, LLC
Trumbull, CT
BK040053CareChek Patient Identification System, CareChek, Version 1.008/12/2005
Kowa Company, Ltd
Rockville, MD
BK030037LD-2000 Leukocyte Counter06/14/2004
Back to Alphabetical Index
L
Lattice, Inc.
Wheaton, IL
BK110055MediCopia Transfusion v4.101/06/2012
Level 1 Technologies, Inc
Rockland, MA
BK020043Level 1 Fluid warming System06/16/2003
LifeSouth Community Blood Centers Inc
Gainesville, FL
BK130054Integrated Blood Bank Information System, Version 3.0 (IBBIS)01/17/2014
LifeSouth Community Blood Centers Inc
Gainesville, FL
BK090064Integrated Blood Bank Information System (IBBIS) Registration Module v2.012/08/2009
Life Technologies Corporation
Brown Deer, WI
BK110038SeCore® HLA Sequencing System
uType® Dx HLA Sequence Analysis Software v 1.0
02/05/2013
Life Technologies Corporation
Brown Deer, WI
BK110039Applied Biosystems 3500 Dx/3500xL Dx Genetic Analyzer CS2 and 3500 Dx Series Data Collection Software02/05/2013
LifeSouth Community Blood Centers Inc
Gainesville, FL
BK080017Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 08/05/2008
LifeTrak/BloodCare
Dallas, TX
BK940048Lab Version 2.0110/01/1998
Ljungber & Kogel
Deerfield, IL
BK090010Biomixer BM330 with XBee (Wireless) Option07/17/2009
Ljungber & Kogel
Deerfield, IL
BK990013Biomixer 330 & Biomixer 32307/07/1999
Back to Alphabetical Index
M
MacoProductions S.A.S.
Marietta, GA
BK080060Leucolab LCG2 Leukoreduction System for AS-1, AS-3, and AS-5 Red Blood Cells01/15/2009
MacoProductions S.A.S.
c/o Hoppe Regulatory Consultants
Decatur, GA
BK050041Leucolab LCG2 Leukoreduction System for Red Blood Cells10/12/2005
Maco Pharma c/o Hoppe Regulatory Consultants
Decatur, GA
BK030008Leucolab LCG2 Leukoreduction System for Red Blood Cells05/02/2003
MAK System
France
BK960050Progesa, Version 4.4a12/10/1998
MAK System SAS International Group
France
BK080002ePROGESA v5.0.105/13/2008
MAK-System
France
BK070062PROGESA 4.4h10/26/2007
MAK-System
France
BK060035Patient Health Software 1.0 05/09/2007
McKesson Provider Technologies
Alpharetta, GA
BK090051Horizon MobileCare Transfusion05/28/2010
Medical Information Technology
Westwood, MA
BK960029Meditech Magic Blood Bank, Version 4.5/4.603/19/1999
Medion Grifols Diagnostics AG
Switzerland
BK140092DG Gel Extended Control04/11/2014
MEDITECH Medical Information Technology, Inc.
Westwood, MA
BK080037MEDITECH Client Server Blood Bank module v5.610/30/2008
MEDITECH Medical Information Technology, Inc
Westwood, MA
BK980046Magic Client Server, Version 5.102/08/2000
Mediware Information Systems, Inc.
Oak Brook, IL
BK120036HCLL™ Transfusion, Version 201209/12/2012
Mediware Information Systems, Inc.
Oak Brook, IL
BK120039LifeTrak® Version 201209/05/2012
Mediware Information Systems, Inc.
Oak Brook, IL
BK100069LifeTrak®/ Plasma, Version 1.0.003/04/2011
Mediware Information Systems, Inc.
Lenexa, KS
BK100057LifeTrak®/ Lab and Distribution, Version 4.6.011/16/2010
Mediware Information Systems, Inc.
Lenexa, KS
BK100043LifeTrak®/Donor, Version 4.6.010/21/2010
Mediware Information Systems, Inc.
Lenexa, KS
BK080061HCLLTM Donor, version 2.012/02/2008
Mediware Information Systems, Inc.
Oak Brook, IL
BK080049HCLL Transfusion, v3.010/22/2008
Mediware Information Systems, Inc.
Irving, TX
BK060019LifeTrak / Donor 3.0106/21/2006
Mediware Information Systems, Inc.
Irving, TX
BK050011HCLL Donor 1.005/10/2005
Mediware Information Systems, Inc.
Irving, TX
BK040047Instrument Interface Engine 1.007/16/2004
Mediware Information Systems, Inc.
Irving, TX
BK030078HCLL 2.604/08/2004
Mediware Information Systems, Inc.
Dallas, TX
BK010052LifeTrak Lab 2.0306/17/2002
Mediware Information Systems, Inc.
Dallas, TX
BK020046Hemocare LifeLine Version, 1.002/14/2003
Mediware Information Systems, Inc.
Melville, NY
BK980034Hemocare Blood Bank Management System Version 5.212/10/1998
Medsep Corporation
Covina, CA
BK120026Pall® Celeris™ fPC System06/29/2012
Medsep Corporation
Covina, CA
BK090007Pall ® Acrodose TM PL System02/25/2009
Medsep Corp
Pepper Pike, OH
BK080003Pall® AcrodoseT PLus System, Platelet Pool and Store Set with in-Line Leukocyte Reduction Filter04/18/2008
Medsep Corporation
Covina, CA
BK070057Pall® Acrodose PLus System Platelet Pool and Store Set with in-line Leukocyte Reduction Filter09/27/2007
Medsep Corporation
Covina, CA
BK070056Pall® Acrodose PLus System Platelet Pool and Store Set with in-line Leukocyte Reduction Filter and eBDS09/27/2007
Medsep Corp
Covina, CA
BK070004Pall eBDS06/26/2007
Medsep Corp
Pepper Pike, OH
BK050074Pall Acrodose PL System01/26/2006
Medsep Corp
Covina, CA
BK050034Pall Acrodose PL System, Platelet Pool and Store Set with eBDS09/28/2005
Medsep Corp
Covina, CA
BK020014Pall Bacterial Detection System (BDS)10/22/2002
Medsep Corp
Covina, CA
BK000032Modified Plasma Bag09/27/2000
Medsep Corp
Covina, CA
BK970040Medsep Plasma Bag (EVA Plastic)01/23/1998
Medserv, Inc
Mount Kisco, NY
BK010032Plasmapheresis Data System III 1.002/05/2002
Medtronic Sofamor Danek
Memphis, TN
BK040068Magellan Autologous Platelet Separator System11/09/2004
Medtronic Sofamor Danek
Memphis, TN
BK030040Magellan Autologous Platelet Separation System09/03/2003
Micro Typing Systems Inc.
Pompano Beach, FL
BK110029ORTHO ProVue ®, version 3.1 Patch 1 (V3.1.1)07/14/2011
Micro Typing Systems Inc.
Pompano Beach, FL
BK090013Ortho ProVue™, Software Version 3.106/04/2009
Micro Typing Systems Inc.
Pompano Beach, FL
BK030023Ortho ProVue, Software Version: 2.1005/30/2003
Micronics, Inc.
Redmond, WA
BK100008ABORhCard®04/30/2010
Microwave Medical System
Acton, MA
BK970045ThermoStat 900 Blood & IV Fluid Adm. Set03/06/1998
Microwave Medical System
Acton, MA
BK970044ThermoStat 90001/23/1998
Miltenyi Biotec, Incorporated
Woburn, MA
BK090020CryoMACS Freezing Bag01/13/2010
Mississippi Blood Services, Inc.
Jackson, MS
BK030065WebLab Online Laboratory System 2.012/22/2003
Misys Healthcare Systems
Tucson, AZ
BK040065Misys Laboratory Blood Bank and Blood Donor 6.0.110/22/2004
Mosum Technology India PVT LTD
Great Neck, NY
BK060014PowerBANK Enterprise Edition version 1.003/30/2007
Back to Alphabetical Index
N
NanoEntek Inc.
Newton, MA
BK120068ADAM-rWBC12/5/2012
NanoEntek Inc.
Newton, MA
BK120015ADAM-rWBC07/24/2012
Neoteric Technology Ltd
Canada
BK060041BloodTrack 4.110/17/2006
Neoteric Technology Ltd
Canada
BK050032BloodTrack SafeTx Version 2.0 08/16/2005
Back to Alphabetical Index
O
Olerup SSP AB
Gaithersburg, MD
BK080022Olerup SSP®HLA Typing Kits02/20/2009
Olympus America Inc
Center Valley, PA
BK090036Olympus PK7300 Automated Microplate System07/27/2009
Olympus America Inc
Irving, TX
BK050076TANGO Automated Blood Bank Analyzer System (HW Version 02/SW Version 3.0)12/16/2005
Olympus America Inc
Irving, TX
BK040070Tango Automated Blood Bank Analyzer System03/22/2005
One Lambda, Inc
Canoga Park, CA
BK130009LABScreen® for use with LABScanTM3D11/06/2013
One Lambda, Inc
Canoga Park, CA
BK120024LABType ® SSO DNA Typing Tests for use with LABScan™3D12/20/2012
One Lambda, Inc
Canoga Park, CA
BK100068HNA Genotyping Trays08/25/2011
One Lambda, Inc
Canoga Park, CA
BK080071LABScreen® Multi04/10/2009
One Lambda, Inc
Canoga Park, CA
BK050070HLA Visual Software version 1.001/30/2006
One Lambda, Inc
Canoga Park, CA
BK050071HLATools Software, Version 1.001/30/2006
One Lambda, Inc
Canoga Park, CA
BK050008LABScreen Software07/08/2005
One Lambda, Inc
Canoga Park, CA
BK040049LabType Visual08/09/2004
One Lambda, Inc
Canoga Park, CA
BK030069LABScreen Products for use with LABScan 100 flow analyzer12/31/2003
One Lambda, Inc
Canoga Park, CA
BK980015FlowPRA07/23/1999
One Lambda, Inc
Canoga Park, CA
BK960062Micro SSP HLA Class II DNA typing Kit02/11/1998
OriGen BioMedical
Austin, TX
BK030036OriGen Cryostore Freezing Bags10/01/2003
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK130032ORTHO™ Workstation08/09/2013
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK130006ORTHO VERSEIA® Integrated Processor (VIP) as part of the ORTHO® Summit System (OSS)5/23/2013
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK120006ORTHO VERSEIA® Pipetter as Part of the ORTHO® Summit03/15/2012
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK110026ORTHO® Summit System06/28/2011
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK100061ORTHO VERSEIA™ Pipetter as part of the ORTHO® Summit System10/28/2010
Ortho-Clinical Diagnostics, Inc
Rochester, NY
BK100040VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls06/17/2010
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK090074Ortho Verseia™ Pipetter as part of the Ortho Summit™ System05/29/2009
Ortho-Clinical Diagnostics, Inc
Rochester, NY
BK070028VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls 04/10/2008
Ortho-Clinical Diagnostics, Inc
Raritan, NJ
BK990030Ortho Lab with Ortho Lab IC (Instrument Concentrator)04/03/2000
Back to Alphabetical Index
P
Pall Life Sciences
Port Washington, NY
BK080014Pall eBDS02/13/2009
Patient Safe™ Solutions, Inc.
San Diego, CA 92121
BK120029Patient Touch™ Blood Product Administration System v3.2.111/13/2012
Pel-Freez Clinical Systems, LLC
Brown Deer, WI
BK000019UniTray SSP HLA Typing Kits01/29/2001
Pel-Freez Clinical Systems, LLC
Brown Deer, WI
BK030003UniMatch Plus02/25/2003
Perfusion Partners & Associates, Inc
Fort Myers, FL
BK050055GenesisCS Component Concentrating System10/13/2006
Prescott Ideas LLC
Tucson, AZ
BK060056Antibody Check 4.104/23/2007
Psyche Systems Corp
Wellesley, MA
BK010017System Blood Bank (SBB) Software 3.009/04/2001
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R
R & D Systems, Inc
Minneapolis, MN
BK040063R & D Plasma Hemoglobin Hematology Control09/17/2004
R & D Systems, Inc
Minneapolis, MN
BK040012R&D Donor Checker Hematology Control03/05/2004
R & D Systems, Inc
Minneapolis, MN
BK000035R & D Leuko-Reduced RBC Control12/13/2000
R & D Systems, Inc
Minneapolis, MN
BK000036R & D Leuko-Reduced Plt Control12/13/2000
Rubin & Poor, Inc
Maplewood, NJ
BK030073Configurable Manual Batch Entry, Version 1.1A01/14/2004
Rubin & Poor, Inc
Maplewood, NJ
BK010025Chiron Procleix NAT Tracker 1.0E01/03/2002
Rubin & Poor, Inc
Maplewood, NJ
BK000030Configurable Laboratory Result Manager (CLRM) 1.0E11/23/2001
Rubin & Poor, Inc
Maplewood, NJ
BK080028Pool Results Manager Version 1.0C, Module for Roche NAT Testing Version 2.0A09/03/2008
Rubin & Poor, Inc
Maplewood, NJ
BK990008Rubin & Poor Configurable Manual Blot System 1.0C10/29/1999
Rowny Systems, Inc.
Bethesda, MD
BK110045Antigen Plus Version 7.405/25/2012
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S
Sanguin International Limited
Hambden, CT
BK100030Sanguin Liberty SRIMPORT 3.107/08/2010
Sanguin International Limited
Hambden, CT
BK090061Sanguin Aurora Version 2.012/22/2009
Sanguin International Limited
Hambden, CT
BK980003Aurora / Fenestra 1.009/29/1999
Sanguin International Limited
Hambden, CT
BK980039Medussa 2000 Srimport, version 1.206/11/1999
Sarstedt, Inc
Newton, NC
BK070029S-Monovette ACD-A Blood Collection System09/21/2007
Sarstedt, Inc
Newton, NC
BK030006Transwaag Disk 0102/27/2003
Sarstedt, Inc
Newton, NC
BK010045Sahara Blood & Plasma Warming Device12/21/2001
Sarstedt, Inc
Newton, NC
BK010042Transwaag KL12/12/2001
SCC Soft Computer
Clearwater, FL
BK140128SoftBank version 25.508/05/2014
SCC Soft Computer
Clearwater, FL
BK100045SoftBank® II Version 25.107/29/2010
SCC Soft Computer
Palm Harbor, FL
BK050045SoftDonor 4.3 with SoftScape 1.2.010/26/2005
SCC Soft Computer
Clearwater, FL
BK090078SoftID.Tx Version 1.012/03/2009
SCC Soft Computer
Clearwater, FL
BK090017SoftBank II® Version 2506/23/2009
SCC Soft Computer
Clearwater, FL
BK080069SoftDonor® Version 4.501/16/2009
SCC Soft Computer
Clearwater, FL
BK080020SoftBank II v23.2 08/12/2008
SCIMEDX Corp
Denville, NJ
BK960070Olympus PK-TP System Control Set06/19/1997
Separation Technology, Inc
Altamonte Springs, FL
BK050056UltraChek Reference Controls - Product Code GLK
UltraCrit Hematocrit Measurement Device - Product Code GKF
12/12/2005
SG Scientific
Gainesville, FL
BK950057The Saber, (Segment Piercing Device)11/13/1995
Shared Medical Systems
Malvern, PA
BK960036SMS Blood Bank Transfusion System12/12/1997
Siemens Healthcare Diagnostics Inc.
Berkeley, CA
BK120013TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System03/27/2012
Siemens Healthcare Diagnostics Inc.
Berkeley, CA
BK110007TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System03/04/2011
Siemens Healthcare Diagnostics Inc.
Berkeley, CA
BK090077TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System12/28/2009
Siemens Healthcare Diagnostics Inc.
Berkeley, CA
BK080073TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System01/15/2009
Sienna Partners
Baldwin, MD
BK040066Greiner VACUETTE No Additive Evacuated Blood Collection Tubes and Serum Clot Activator Blood Collection Tubes09/10/2004
Sienna Partners
Baldwin, MD
BK040018VACUETTE EDTA K2 tube
VACUETTE EDTA K3 tube
07/28/2004
Smith & Nephew, Inc
Memphis, TN
BK060004Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System05/02/2006
Soft Computer Consultants, Inc
Palm Harbor, FL
BK040048SoftBank II v23.1 with Database Management System Interface (DMSI)08/23/2004
Soft Computer Consultants, Inc
Palm Harbor, FL
BK040028SoftBank II version 23 with SoftScape 05/07/2004
Soft Computer Consultants, Inc
Palm Harbor, FL
BK030018SoftBank II 2304/17/2003
Soft Computer Consultants, Inc
Palm Harbor, FL
BK020006SoftDonor 4.102/27/2003
Soft Computer Consultants, Inc
Palm Harbor, FL
BK020021SoftBank II 2209/11/2002
Soft Computer Consultants, Inc
Palm Harbor, FL
BK000040Softbank II Version 21.104/20/2001
Soft Computer Consultants, Inc
Palm Harbor, FL
BK960033Softbank II Version 19.107/10/1998
Spine Smith Partners, LLC
Austin, TX
BK090047Fusionary Graft Delivery System02/10/2010
Stemco Biomedical, Inc
Durham, NC
BK040075Aldecount Progenitor Cell Enumeration Kit01/06/2005
Stemco Biomedical, Inc
Durham, NC
BK030064Aldecount Progenitor Cell Enumeration Kit12/31/2003
Sunquest Information Systems, Inc.
Tucson, AZ
BK140124Sunquest Transfusion Manager, version 2.006/18/2014
Sunquest Information Systems, Inc.
Tucson, AZ
BK080042Sunquest Blood Bank Donor 6.403/03/2009
Sunquest Information Systems, Inc.
Tucson, AZ
BK990034FlexiLab Blood Bank and Blood Donor System, version 5.211/17/1999
Sunquest Information Systems, Inc.
Tucson, AZ
BK990002Flexilab Blood Bank and Blood Donor, Version 5.208/16/1999
Sunquest Information Systems, Inc.
Tucson, AZ
BK080021Sunquest Transfusion Manager v1.012/03/2008
SynGen, Inc. Sacramento, CABK120061SynGenX-100007/11/2013
SysLogic, Inc.
Brookfield, WI
BK120067iTrace for Blood Centers, v 1.0.924.05/28/2013
Sysmex America, Inc.
Mundelein, IL
BK080067Sysmex® XE-2100D09/28/2009
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK060032LifeTec Elite 1.008/21/2006
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK040026LifeTec Donor Verification and Collection System (DOVAC) 1.0010/21/2004
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK990003LifeTec, Version 2.2007/30/1999
SysTec Computer Associates, Inc
Mt. Sinai, NY
BK960034LifeTec Community Blood Center System Revision 2.1007/28/1998
Back to Alphabetical Index
T
Talisman Ltd
Vienna, VA
BK070020Quality Donor System v2.107/16/2007
Talisman Ltd
Vienna, VA
BK060031Talisman Phlebotomy System, Release 1.007/27/2006
Talisman Ltd
Vienna, VA
BK040062Quality Donor System 2004 2.010/18/2004
Tepnel Lifecodes Corporation
Stamford, CT
BK090018LIFECODES Evolution Software, version 1.006/04/2009
Tepnel Lifecodes Corporation
Stamford, CT
BK050003LIFECODES HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB Typing Kits for use with Luminex 10007/18/2005
Terumo BCT, Inc
Lakewood, CO
BK140158Trima Accel System 6.408/29/2014
Terumo BCT, Inc
Lakewood, CO
BK140104Vista Information System, Version 3.204/01/2014
Terumo BCT, Inc.
Lakewood, CO
BK130080Trima Accel® System, Version 6.203/19/2014
Terumo BCT, Inc.
Lakewood, CO
BK130065Spectra Optia® Apheresis System01/16/2014
Terumo BCT, Inc.
Lakewood, CO
BK130031Spectra Optia® Apheresis System07/25/2013
Terumo BCT, Inc.
Lakewood, CO
BK120076Spectra Optia® Apheresis System02/26/2013
Terumo BCT, Inc.
Lakewood, CO
BK120040Trima Accel® System10/4/2012
Terumo BCT, Inc.
Lakewood, CO
BK120012Spectra Optia® Apheresis System07/09/2012
Terumo BCT, Inc.
Lakewood, CO
BK120017Trima Accel Automated Blood Component Collection System05/31/2012
Terumo BCT, Inc.
Lakewood, CO
BK110068Trima Accel® Automated Blood Component Collection System03/23/2012
Terumo Medical Corp
Lakewood, CO
BK110071TSCD®II Sterile Tubing Welder with or without Trucise® Total System09/12/2012
Terumo Medical Corp
Elkton, MD
BK040082TSCD-II Terumo Sterile Tubing Welder 04/05/2005
Terumo Medical Corp
Elkton, MD
BK020033Imugard III-PL Leukocyte reduction filter05/22/2003
Terumo Medical Corp
Elkton, MD
BK970008Terumo Sterile Tubing Welder SC-201A (TSCD)05/28/1998
Terumo Medical Corp
Elkton, MD
BK970011Terumo Phlebotomy Needle Cap Holder06/19/1997
Texas BioGene, Inc
Richardson, TX
BK080039Morgan™ HLA SSP ABDRDQ Typing Kit04/22/2009
Texas BioGene, Inc
Richardson, TX
BK060060Morgan HLA SSP ABDR Typing Kit03/22/2007
Thermogenesis
Rancho Cordova, CA
BK100066Res-Q 60 PRP Device05/27/2011
Thermogenesis
Rancho Cordova, CA
BK960072CryoSeal System02/12/1999
Thermogenesis
Rancho Cordova, CA
BK070006AXP AutoXpress Platform10/05/2007
The Surgical Company International
Netherlands
BK070055Fluido Accessories: Fluido Air Guard, Fluido Compressor, Fluido IV-Pole and Fluido Pressure Chamber 01/15/2008
The Surgical Company International
Netherlands
BK050058Fluido Blood and Fluid Warmer System 05/05/2006
Back to Alphabetical Index
U
Utah Medical Products, Inc
Midvale, UT
BK970026Umbilicup01/28/1998
Back to Alphabetical Index
V
VEEGEE Scientific
Kirkland, WA
BK010043Atago SP-D2 Refractometer01/02/2002
Verax Biomedical Inc
Worcester, MA
BK110014Platelet PGD® Test System09/08/2011
Verax Biomedical Inc
Worcester, MA
BK070044Platelet PGD Test System09/17/2007
Verax Biomedical Inc
Worcester, MA
BK090028Platelet PGD Test System11/10/2009
Visible Genetics, Inc
Canada
BK000038TRUEGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System09/26/2001
Back to Alphabetical Index
W
Wyndgate Technologies
El Dorado Hills, CA
BK090033ElDorado Donor Doc10/28/2009
Wyndgate Technologies
El Dorado Hills, CA
BK090063Test Result Interface for ElDorado Donor11/20/2009
Wyndgate Technologies
El Dorado Hills, CA
BK070064ElDorado Donor 1.0.0 02/13/2008
Wyndgate Technologies
El Dorado Hills, CA
BK070010ElDorado Donor Doc 1.0.005/23/2007
Wyndgate Technologies
Rancho Cordova, CA
BK980023SafeTrace TX, version 1.001/29/1999
Wyndgate Technologies
Rancho Cordova, CA
BK100002Component Manufacturing Interface for ElDorado Donor02/01/2010
Wyndgate Technologies
Rancho Cordova, CA
BK950059Safe Trace Version 1.004/14/1997
Back to Alphabetical Index
Z
ZLB Behring AG
Switzerland
BK050078System for Plasma Identification (SPI) 2.0.0 12/22/2005
ZLB Bioplasma AG
Switzerland
BK020020System for Plasma Identification (SPI) 1.010/30/2002
Back to Alphabetical Index

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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