Vaccines, Blood & Biologics
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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 |
|---|---|---|---|
| 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 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 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 | BK020031 | ASI TPHA Test | 01/30/2003 |
| Arthrex Incorporated Naples , FL | BK070069 | Arthrex Double Syringe (ACP, Autologous Conditioned Plasma) System | 12/12/2008 |
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| 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 |
| BioErgonomics, Inc St. Paul, MN | BK000046 | FluoroTrol Control Kits | 04/02/2001 |
| 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 |
| 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 | 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 |
| Back to Alphabetical Index | |||
| 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 |
| 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 |
| CSL Behring AG Switzerland | BK110023 | System for Plasma Identification (SPI), version 3.1.0 | 06/08/2011 |
| 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 |
| Back to Alphabetical Index | |||
| 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 | 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 |
| 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 |
| 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 |
| Back to Alphabetical Index | |||
| Eclipsys Corporation Malvern, PA | BK090044 | Sunrise Blood Bank version 2.0 SP2 | 11/13/2009 |
| Estar Technologies Ltd. New York, NY | BK110035 | TropoCells Autologous Platelet Preparation Kit Regulation | 03/28/2012 |
| Back to Alphabetical Index | |||
| 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, 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 | |||
| 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 | 30/15/2005 |
| 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 |
| 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 |
| 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 |
| 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 | |||
| 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 |
| Harvest Technologies Norwell, MA | BK000037 | Harvest PRP Separation System | 02/05/2001 |
| 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 |
| 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 |
| 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 | |||
| 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 |
| lmmunetics, 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 |
| 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 39232 | BK110064 | DoVac Elite v1.0 | 09/06/2012 |
| Back to Alphabetical Index | |||
| 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 | |||
| 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 | BK090064 | Integrated Blood Bank Information System (IBBIS) Registration Module v2.0 | 12/08/2009 |
| 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 | |||
| 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 |
| 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 | 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 | 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 |
| Back to Alphabetical Index | |||
| 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 |
| Back to Alphabetical Index | |||
| 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 | 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 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 | |||
| Pall Life Sciences Port Washington, NY | BK080014 | Pall eBDS | 02/13/2009 |
| 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 |
| Psyche Systems Corp Wellesley, MA | BK010017 | System Blood Bank (SBB) Software 3.0 | 09/04/2001 |
| Back to Alphabetical Index | |||
| 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 |
| Back to Alphabetical Index | |||
| 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 | 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. 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 | 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 |
| 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 | |||
| 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 | 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 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 |
| Back to Alphabetical Index | |||
| Utah Medical Products, Inc Midvale, UT | BK970026 | Umbilicup | 01/28/1998 |
| Back to Alphabetical Index | |||
| VEEGEE Scientific Kirkland, WA | BK010043 | Atago SP-D2 Refractometer | 01/02/2002 |
| 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 | |||
| 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 | |||
| 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 | |||
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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