Vaccines, Blood & Biologics
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510(k) Blood Establishment Computer Software
Software is listed in alphabetical order by applicant.
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 | Device Name | 510(k) Number | Clearance Date |
Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 | Abbott Apheresis Tracking System (AARTS) Version 1.0 | BK950048 | 06/24/1998 |
Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 | Abbott DMS II Version 1.5 | BK950052 | 08/12/1998 |
Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 | Abbott DMS Version 3.0.2 | BK950032 | 08/18/1998 |
Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064-3500 | Abbott Prism Retest | BK010036 | 07/17/2002 |
ADAC HealthCare Information System 5 Greenway Plaza, Suite 1900 Houston, TX 77046 | LabCare Blood Bank II Version 13.3 | BK960027 | 08/12/1998 |
American Blood Resources Association PO Box 669 Annapolis, MD 21404 | National Donor Deferral Registry Version 2.0 | BK960030 | 03/20/1997 |
American Blood Resources Association 147 Old Solomons Island Road Annapolis, MD 21401 | National Donor Deferral Registry Ver 1.0 | BK010012 | 09/06/2001 |
American Red Cross Washington, DC 20006 | National Biomedical Computer System, Version 1.1 | BK960040 | 02/28/1997 |
American Red Cross Blood Services Arlington, VA 22209 | NGTL Automation system (NAS) 5.2.0 | BK020032 | 03/20/2003 |
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Bayer Corp 800 Dwight Way Berkeley, CA 94701 | Plasma Procurement Information System Version 2.0 | BK960051 | 08/07/1998 |
Bayer Corp 800 Dwight Way Berkeley, CA 94701 | Plasma Procurement Information System (PPIS), version 3.0 | BK990024 | 11/03/1999 |
Bayer Corp 800 Dwight Way Berkeley, CA 94701 | Plasma Procurement Information System (PPIS), version 4.0 | BK990037 | 11/17/1999 |
Baxter Healthcare Corp 550 North Brand Blvd Glendale, CA 91203 | Serology SQL LIMS 1.0 | BK020002 | 08/07/2002 |
BBK Technology LLC 2910 E. Highland Ave. Phoenix, AZ 85016 | RC-AID, version 2.0 | BK100037 | 09/13/2010 |
Becton, Dickinson & Company 1 Becton Drive, MC 300 Franklin Lakes, NJ 07417-1885 | Bd.id Patient Identification System for Transfusion Management V7.00 | BK060046 | 02/13/2007 |
BioLife Plasma Services LP One Baxter Parkway Deerfield IL 60015 | Donor Information System (DIS) version 4.0 | BK090001 | 08/18/2009 |
BioLife Plasma Services LP One Baxter Parkway Deerfield IL 60015 | Donor Information System v3.3 | BK080016 | 07/02/2008 |
BioLife Plasma Services LP One Baxter Parkway Deerfield IL 60015 | Donor Information System (DIS) 3.2 | BK060017 | 05/09/2006 |
BioLife Plasma Services LP One Baxter Parkway Deerfield IL, 60015 | Donor Information System (DIS) 3.1 | BK050029 | 07/07/2005 |
Biomat USA, Inc. 13111 Temple Avenue City of Industry, CA 91746 | System for Plasma Identification (SPI), Version 2.0.0 | BK090082 | 10/01/2010 |
Biosafe SA Route du Petit Eysins 1 1262 Eysins (Vaud) Switzerland | Sepax Cell Separation System and Single-Use Kits, Sepax 2 S-100 | BK110022 | 10/28/2011 |
Blood Bank Computer Systems, Inc 1002 15th SW, Suite 120 Auburn, WA 98001-6502 | BBCS BloodTrack Interface Application (BBCSBT), BT 1.0.0 Blood Bank Control System version 5.0 | BK120028 | 06/21/2012 |
Blood Bank Computer Systems, Inc 1002 15th SW, Suite 120 Auburn, WA 98001-6502 | BBCS Hospital Interface Application (BBCSH), H 1.0.0 | BK090081 | 12/23/2009 |
Blood Bank Computer Systems, Inc 1002 15th SW, Suite 120 Auburn, WA 98001-6502 | BBCS Mobile Application 5.0M | BK050013 | 06/01/2005 |
Blood Bank Computer Systems, Inc 1002 15th SW, Suite 120 Auburn, WA 98001-6502 | BBCS Lab Interface Application (BBCS Lab) 5.0L | BK040087 | 02/15/2005 |
Blood Bank Computer Systems, Inc 1002 15th SW, Suite 120 Auburn, WA 98001-6502 | Blood Bank Control System (BBCS) 5.0 | BK040056 | 10/22/2004 |
Blood Bank Computer Systems, Inc 1501 West Valley Hwy, Suite 101 Auburn, WA 98001 | Blood Bank Control System Version 4.0/4.1/4.2/4.3 | BK960044 | 10/15/1997 |
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Calimex USA Corporation 258 Hollister Ave Alameda, CA 94501 | eOrders, Version 1 | BK110070 | 02/17/2012 |
Calimex USA Corporation 258 Hollister Ave Alameda, CA 94501 | Picture-ID | BK090054 | 01/11/2010 |
Care Fusion, Inc. 1430 Spring Hill Road, Suite 510 McLean, VA 22102 | wBlood Care 1.0 | BK040002 | 11/10/2004 |
CaridianBCT, Inc. 10811 W. Collins Ave. Lakewood, CO 80215 | Trima Accel Automated Blood Component Collection System | BK110051 | 12/20/2011 |
Carter BloodCare 2205 Highway 121 Bedford, TX 76021 | LifeTrak / Distribution, version 2.03 | BK990015 | 10/22/1999 |
Carter BloodCare 2205 Highway 121 Bedford, TX 76021 | LifeTrak / Donor, version 2.03 | BK990027 | 12/15/1999 |
Cerner Corp 2800 Rockcreek Parkway Kansas City, MO 64117 | PathNet Blood Bank Center Version 306 | BK950051 | 07/16/1997 |
Cerner Corp 2800 Rockcreek Parkway Kansas City, MO 64117 | PathNet Blood Bank Transfusion Version 306 | BK950053 | 07/16/1997 |
Cerner Corp 2800 Rockcreek Parkway Kansas City, MO 64117 | PathNet Blood Bank Donor Version 306 | BK950055 | 07/16/1997 |
Cerner Corp 2800 Rockcreek Parkway Kansas City, MO 64117 | PathNet Worksystems Blood Bank Transfusion Version 306 | BK960024 | 07/16/1997 |
Cerner Corp 2800 Rock Creek Parkway Kansas City, MO 64117 | HNA Millennium PathNet Blood Bank Transfusion | BK990007 | 11/02/1999 |
Cerner Corp 2800 Rock Creek Parkway Kansas City, MO 64117 | Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 | BK030028 | 08/19/2003 |
Cerner Corp 2800 Rock Creek Parkway Kansas City, MO 64117 | Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.3 | BK060037 | 05/24/2007 |
Chiron Corporation 4560 Horton Street Emeryville, CA 94608-2916 | Chiron Procleix NAT Tracker 3.0 | BK060005 | 03/01/2006 |
Community Bio-Resources, Inc 2197 Parkway Lake Drive Hoover, AL 35244 | Donor Information System Version 1.0 | BK970007 | 04/09/1997 |
Community Blood Centers of South Florida 1700 North State Road 7 Lauderhill, FL 33313 | Regulated Software Application (RSA) | BK110048 | 01/12/2012 |
Community Blood Center of Greater Kansas City 4040 Main Street Kansas City, MO 64117 | CBC Blood System Version 1.2 | BK960060 | 11/20/1997 |
CSL Behring AG Wankdorfstrasse 10 3014 Bern Switzerland | System for Plasma Identification (SPI), version 3.1.0 | BK110023 | 06/08/2011 |
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Data Innovations, Inc South Burlington, VT | Instrument Manager v8.10 | BK100046 | 08/12/2010 |
Data Innovations, Inc. 120 Kimball Ave., Suite 100 South Burlington, VT 05430 | Instrument Manager 8.05.01.10 | BK060053 | 01/05/2007 |
Data Innovations, Inc. 120 Kimball Ave., Suite 100 South Burlington, VT 05430 | imExpress 7.2.5 | BK020057 | 07/29/2003 |
Department of Defense 5205 Leesburg Pike Suite 1000 Falls Church VA 22041 | Defense Blood Standard System (DBSS) 10.0.0 | BK070035 | 05/22/2008 |
Department of Defense 5 Skyline Plaza Falls Church, VA 22047 | Defense Blood Standard System Versions 1.00/1.03 | BK960004 | 08/01/1997 |
Department of Defense 5113 Leesburg Pike, Suite 701 Falls Church, VA 22041 | Defense Blood Standard System Version 3.00 | BK980031 | 08/31/1998 |
Department Of Veterans Affairs P.O. Box 7008 Hines, IL 60141-7008 | VistA Blood Establishment Computer Software (VBECS) 1.0 | BK060043 | 10/19/2006 |
Department Of Veterans Affairs P.O. Box 5000 VA Hines Medical Center Hines, IL 60141 | Vista Blood Bank, Version 5.2 | BK970021 | 04/23/1999 |
Digi-Trax 1550 Barclay Blvd Buffalo Grove, IL 60089 | Donor - ID Version 1.0 | BK970013 | 02/27/1998 |
Digi-Trax 1550 Barclay Blvd Buffalo Grove, IL 60089 | Digi-Trax Donor-ID Version 2.0 | BK000020 | 04/20/2000 |
Digi-Trax 1550 Barclay Blvd Buffalo Grove, IL 60089 | Donor-ID 2.2 | BK010049 | 04/26/2002 |
Duley Hopkins and Associates 1200 Mountain Creek Road Chattanooga , TN 37405 | Blood Bank Information Management System (BBIMS) v2.05.01 | BK090079 | 01/13/2010 |
Duley Hopkins and Associates 1200 Mountain Creek Road Chattanooga , TN 37405 | Blood Bank Information Management System (BBIMS) | BK070065 | 04/25/2008 |
Dynamic Healthcare Techonologies, Inc 101 Southhall Lane, Suite 210 Maitland, FL 32751 | Transfusion Service Manager Version 4.1.6 | BK960041 | 12/16/1997 |
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Eclipsys Corporation 450 Lapp Road Malvern, PA 19355 | Sunrise Blood Bank, version 2.0 SP2 | BK090044 | 11/13/2009 |
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Fenwal Inc. Three Corporate Drive Lake Zurich, IL 60047 | AMICUS Separator System with Software Version 4.3 | BK110030 | 12/23/2011 |
Fenwal Inc. Three Corporate Drive Lake Zurich, IL 60047 | Fenwal DXT Relay, Software Version 2.0 | BK110025 | 08/22/2011 |
Fenwal Inc. Three Corporate Drive Lake Zurich, IL 60047 | AMICUS® Separator: Software 3.1 with EDI Export | BK080048 | 10/02/2008 |
Fifth Dimension Information Systems Suite 500, 10025- 102A Avenue Edmonton, Alberta T5J 2Z2 CANADA | E-Interview (eQue) 1.0.0 | BK050060 | 05/24/2006 |
Fifth Dimension Information Systems Suite 500, 10025- 102A Avenue Edmonton, Alberta T5J 2Z2 CANADA | LOGIC 2.0 | BK040040 | 10/06/2004 |
Fifth Dimension Information Systems Suite 500 Midland Walwyn Tower Edmonton Centre Edmonton, Alberta Canada T5J2Z2 | Plasma Center Module, Version 1.0 | BK980025 | 05/18/1999 |
Fifth Dimension Information Systems Suite 500 Merril Lynch Tower Edmonton Centre Edmonton, Canada | Donor Management System, version 1.0.0 | BK990022 | 09/10/1999 |
Fifth Dimension Information Systems Suite 500 Edmonton, Alberta Cananda T5J2Z2 | P2K Plasma Center Module 2000 Version 1.0 | BK000026 | 06/22/2000 |
Fifth Dimension Information Systems Suite 500, Merril Lynch Tower Edmonton Centre Edmonton, Alberta, T5J 2Z2 CANADA | LOGIC 1.0 | BK020058 | 02/03/2003 |
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Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 | Vista Information System, Version 3.0 with Medical Review Module | BK070066 | 12/13/2007 |
Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 | Vista Information System, Independent Solution | BK020015 | 07/15/2002 |
Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 | Vista Information System 2.1 | BK030021 | 05/01/2003 |
GE Medical Information Technologies 540 Northwest Highway Barrington, IL 60010 | Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 | BK050018 | 06/13/2005 |
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Haemonetics Corporation 10025 102A Avenue, Suite 500 Edmonton, Alberta, Canada T5J 2Z2 | LOGIC Version 3.0.0 | BK120002 | 04/24/2012 |
Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 | Nextgen, version 1.0.0 | BK110015 | 06/13/2011 |
Haemonetics Corporation 400 Wood Road Braintree, MA 02184-9114 | Symphony System 3.0 | BK090041 | 09/28/2009 |
Healthcare-ID 1635 Barclay Blvd Buffalo Grove IL 60089 | Donor-ID™ Web Version 3.2 integrated with biometric finger identification technology, optional | BK120030 | 06/25/2012 |
Healthcare-ID 1635 Barclay Blvd Buffalo Grove IL 60089 | Donor-ID Web™, version 3.1.4 | BK080044 | 06/10/2009 |
Healthcare-ID 1635 Barclay Blvd Buffalo Grove IL 60089 | Donor-ID 3.0 | BK060058 | 02/08/2007 |
Healthcare-ID 1635 Barclay Blvd. Buffalo Grove, IL 60089 | Donor-ID version 2.5 | BK030049 | 10/31/2003 |
Healthcare Management Systems, Inc 3102 West End Avenue, Suite 400 Nashville, TN 37203 | Monitor Blood Administration Module Release 24.0 | BK050001 | 09/28/2005 |
Healthcare Management Systems, Inc. 3102 West End Ave., Suite 400 Nashville, TN 37203 | HMS Blood Administration Module, Release 8.0 | BK090025 | 03/04/2010 |
Helmer Labs, Inc 15425 Herriman Boulevard Noblesville, IN 46060 | UltraCW (with Software version 3.13) | BK020029 | 10/04/2002 |
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Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 | ImmuLINK, version 2.0 | BK120016 | 06/14/2012 |
Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 | Galileo NeoTM Automated Blood Bank System | BK100033 | 08/23/2010 |
lmmunetics, Inc. 27 Drydock Avenue Boston, MA 02210 | BacTx® Bacterial Detection Kit for Platelets | BK110054 | 06/11/2012 |
Information Data Management, Inc 9701 West Higgins Rd Rosemont, IL 60018 | IDM Symphony System 2.0 | BK070031 | 12/13/2007 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 | IDM Surround system 3.0 | BK010028 | 08/30/2001 |
Information Data Management, Inc 9701 West Higgins Rd Rosemont, IL 60018 | Components and Distribution Information System Version 1.0 | BK950037 | 08/26/1996 |
Information Data Management, Inc 9701 West Higgins Rd Rosemont, IL 60018 | Donor Mgmt. Information System Version 1.2 | BK950045 | 08/26/1996 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 | Plasma Center Management System Version 1.0 | BK980020 | 07/31/1998 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 | Plasma Center Management System Version 1.1 | BK980028 | 09/04/1998 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 | Surround System 1.0 | BK990016 | 08/27/1999 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 | Plasma Center Management System (PCMS), Version 1.2 | BK990029 | 10/13/1999 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 | Plasma Center Management System (PCMS), Version 2.0 | BK990046 | 01/06/2000 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 | Surround System 2.0 | BK000016 | 04/07/2000 |
Information Data Management Systems, Inc 9701 west Higgins Road Rosemont, IL 60018 | Surround System, Version 3.2 | BK020038 | 10/08/2002 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 | IDM Prelude System, Version 1.1 | BK050014 | 07/18/2005 |
Informedics, Inc 4000 Kruse Way Place, Building 3 Lake Oswego, OR 97035 | Lifeline Blood Bank Management System Release 4.2 | BK950064 | 07/01/1998 |
IT Synergistics, LLC 115 Tree Street Flowood, MS 39232 | DoVac Elite v1.0 | BK110064 | 09/06/2012 |
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Korchek Technologies, LLC 770 Plattsville Road Trumbull, CT 06611 | CareChek Patient Identification System, CareChek, Version 1.0 | BK040053 | 08/12/2005 |
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Lattice, Inc. 1751 South Naperville Road Wheaton, IL 60189 | MediCopia Transfusion v4.1 | BK110055 | 01/06/2012 |
LifeSouth Community Blood Centers Inc. 4039 W. Newberry Road Gainesville, FL 32607 | Integrated Blood Bank Information System | BK090064 | 12/08/2009 |
LifeSouth Community Blood Centers Inc 4039 W. Newberry Road Gainesville, FL 32607 | Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 | BK080017 | 08/05/2008 |
LifeTrak/BloodCare 9000 Harry Hines Blvd. Dallas, TX 75235 | Lab Version 2.01 | BK940048 | 10/01/1998 |
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MAK System SAS International Group 10 Avenue de la Grande Armee Paris 75017 FRANCE | ePROGESA v5.0.1 | BK080002 | 05/13/2008 |
MAK-System 10 Avenue de la Grande Armee FRANCE | PROGESA 4.4h | BK070062 | 10/26/2007 |
MAK System 10 Avenue de la Grande Armee Paris, France | Patient Health Software 1.0 | BK060035 | 05/09/2007 |
MAK System Z.1. Paris Nord II 13, Rue de la Perdix B.P. 50035 95946 Roissy C.D.G. CEDEX, France | Progesa, Version 4.4a | BK960050 | 12/10/1998 |
Medical Information Technology Meditech Circle Westwood, MA 02090 | Meditech Magic Blood Bank, Version 4.5/4.6 | BK960029 | 03/19/1999 |
Medical Information Technology Meditech Circle Westwood, MA 02090 | Magic Client Server, Version 5.1 | BK980046 | 02/08/2000 |
MEDITECH Medical Information Technology, Inc. MEDITECH Circle Westwood, MA 02090 | MEDITECH Client Server Blood Bank module v5.6 | BK080037 | 10/30/2008 |
Mediware Information Systems, Inc. 1900 Spring Road, Suite 450 Oak Brook, IL 60523 | HCLLTM Transfusion 2012 | BK120036 | 9/12/2012 |
Mediware Information Systems, Inc. 1900 Spring Road, Suite 450 Oak Brook, IL 60523 | LifeTrak® Version 2012 | BK120039 | 9/5/2012 |
Mediware Information Systems, Inc. 1900 Spring Road, Suite 450 Oak Brook, IL 60523 | LifeTrak®/ Plasma, Version 1.0.0 | BK100069 | 03/04/2011 |
Mediware Information Systems, Inc., 11711 West 79th Street Lenexa, KS 66214 | LifeTrak®/ Lab and Distribution, Version 4.6.0 | BK100057 | 11/16/2010 |
Mediware Information Systems, Inc., 11711 West 79th Street Lenexa, KS 66214 | LifeTrak®/Donor, Version 4.6.0 | BK100043 | 10/21/2010 |
Mediware Information Systems, Inc. Lenexa, KS 66214 | HCLLTM Donor, version 2.0 | BK080061 | 12/02/2008 |
Mediware Information Systems, Inc. 1900 Spring Road, Suite 450 Oak Brook Service Center Oak Brook, IL 60523 | HCLL Transfusion, v3.0 | BK080049 | 10/22/2008 |
Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 | LifeTrak / Donor 3.01 | BK060019 | 06/21/2006 |
Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 | HCLL Donor 1.0 | BK050011 | 05/10/2005 |
Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 | Instrument Interface Engine 1.0 | BK040047 | 07/16/2004 |
Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 | HCLL 2.6 | BK030078 | 04/08/2004 |
Mediware Information Systems, Inc 9000 Harry Hines Blvd Dallas, TX 75235 | LifeTrak Lab 2.03 | BK010052 | 06/17/2002 |
Mediware Information Systems, Inc 1121 Old Walt Whitman Road Melville, NY 11747 | Hemocare Blood Bank Management System Version 5.2 | BK980034 | 12/10/1998 |
Mediware Information Systems, Inc 900 Oakmont Lane Westmont, IL, 60659 | Hemocare LifeLine Version, 1.0 | BK020046 | 02/14/2003 |
Medserv, Inc 71 South Bedford Road Mount Kisco, NY 10549 | Plasmapheresis Data System III 1.0 | BK010032 | 02/05/2002 |
Micro Typing Systems Inc. Pompano Beach, FL | ORTHO ProVue ®, version 3.1 Patch 1 (V3.1.1) | BK110029 | 07/14/2011 |
Micro Typing Systems Inc. Pompano Beach, FL | Ortho ProVue™, Software Version 3.1 | BK090013 | 06/04/2009 |
Mississippi Blood Services, Inc. 1995 Lakeland Drive Jackson, MS 39216 | WebLab Online Laboratory System 2.0 | BK030065 | 12/22/2003 |
Misys Healthcare Systems 4801 East Broadway Boulevard Tucson, AZ 85711 | Misys Laboratory Blood Bank and Blood Donor 6.0.1 | BK040065 | 10/22/2004 |
Mosum Technology India PVT LTD 55 Northern Blvd, Suite 200 Great Neck, NY 11021 | PowerBANK Enterprise Edition version 1.0 | BK060014 | 03/30/2007 |
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Neoteric Technology Ltd 205-1099 W. 8th Ave. Vancouver British Columbia V6H 1C3 CANADA | BloodTrack 4.1 | BK060041 | 10/17/2006 |
Neoteric Technology Ltd 205-1099 W. 8th Ave. Vancouver British Columbia V6H 1C3 CANADA | BloodTrack SafeTx Version 2.0 | BK050032 | 08/16/2005 |
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Ortho-Clinical Diagnostics, Inc 1001 U.S. Highway 202 Raritan, NJ 08869-0606 | ORTHO® Summit System | BK110026 | 06/28/2011 |
Ortho-Clinical Diagnostics, Inc 1001 U.S. Highway 202 Raritan, NJ 08869-0606 | Ortho Verseia™ Pipetter as part of the Ortho Summit™ System | BK090074 | 05/29/2009 |
Ortho-Clinical Diagnostics, Inc 1001 U.S. Highway 202 Raritan, NJ 08869 | Ortho Lab with Ortho Lab IC (Instrument Concentrator), Version 1.0 | BK990030 | 04/03/2000 |
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Prescott Ideas LLC 8960 E. Anna Place Tucson, AZ 85710 | Antibody Check 4.1 | BK060056 | 04/23/2007 |
Psyche Systems Corp Ten Laurel Avenue Wellesley, MA 02481 | System Blood Bank (SBB) Ver. 3.0 | BK010017 | 09/04/2001 |
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Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 | Pool Results Manager Version 1.0C, Module for Roche NAT Testing Version 2.0A | BK080028 | 09/03/2008 |
Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 | Configurable Manual Batch Entry, Verion 1.1A | BK030073 | 01/14/2004 |
Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 | Configurable Laboratory Result Manager (CLRM) 1.0E | BK000030 | 11/23/2001 |
Rubin & Poor, Inc 150 West 25th Street, Suite 600 New York, NY 10001 | Rubin & Poor Configurable Manual Blot System, version 1.0C | BK990008 | 10/29/1999 |
Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 | Chiron Procleix NAT Tracker 1.0E | BK010025 | 01/03/2002 |
Rowny Systems, Inc. 7555 Spring Lake Drive Bethesda, MD 20817-6507 | Antigen Plus Version 7.4 | BK110045 | 05/25/2012 |
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Sanguin International 1020 Sherman Avenue Hamden, CT 06514 | Sanguin Liberty SRIMPORT 3.1 | BK100030 | 07/08/2010 |
Sanguin International 1020 Sherman Avenue Hamden, CT 06514 | Sanguin Aurora version 2.0 | BK090061 | 12/22/2009 |
Sanguin International 1020 Sherman Avenue Hamden, CT 06514 | Medussa 2000 Srimport, version 1.2 | BK980039 | 06/11/1999 |
SCC Soft Computer 5400 Tech Data Drive Clearwater FL 33760 | SoftBank II® Version 25 | BK090017 | 06/23/2009 |
SCC Soft Computer 5400 Tech Data Drive Clearwater FL 33760 | SoftDonor® Version 4.5 | BK080069 | 01/16/2009 |
SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 | SoftBank II v23.2 | BK080020 | 08/12/2008 |
SCC Soft Computer 34350 US Highway 19 North Palm Harbor, FL 34684 | SoftDonor 4.3 with SoftScape 1.2.0 | BK050045 | 10/26/2005 |
SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760 | SoftID.Tx Version 1.0 | BK090078 | 12/03/2009 |
SCC Soft Computer, Inc. 5400 Tech Data Drive Clearwater, FL 33760 | SoftBank® II Version 25.1 | BK100045 | 07/29/2010 |
Shared Medical Systems 51 Valley Stream Parkway Malvern, PA 19355 | SMS Blood Bank Transfusion System Versions 2.0/3.0/4.0 | BK960036 | 12/12/1997 |
Siemens Healthcare Diagnostics, Inc. P.O. Box 2466 Berkeley, CA 94702 | TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing System | BK120013 | 03/27/2012 |
Soft Computer Consultant 34350 US Highway 19 North Palm Harbor, FL 34684 | SoftBank II v23.1 with Database Management system Interface (DMSI) | BK040048 | 08/23/2004 |
Soft Computer Consultant 34350 US Highway 19 North Palm Harbor, FL 34684 | Softbank II Version 19.1 | BK960033 | 07/10/1998 |
Soft Computer Consultants 34350 US Highway 19 North Palm Harbor, FL 34684 | Softbank II Version 21.1 | BK000040 | 04/20/2001 |
Soft Computer Consultants, Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 | SoftBank II 22 | BK020021 | 09/11/2002 |
Soft Computer Consultants, Inc 34350 U.S. Hwy 19 N Palm Harbor, FL, 34684 | SoftDonor 4.1 | BK020006 | 02/27/2003 |
Soft Computer Consultants, Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 | SoftBank II 23 | BK030018 | 04/17/2003 |
Soft Computer Consultants, Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 | SoftBank II version 23 with SoftScape | BK040028 | 05/07/2004 |
Sunquest Information Systems 250 S. Williams Blvd. Tucson, AZ 85711 | Sunquest Blood Bank Donor 6.4 | BK080042 | 03/03/2009 |
Sunquest Information Systems 250 S. Williams Blvd. Tucson, AZ 85711 | Sunquest Transfusion Manager v1.0 | BK080021 | 12/03/2008 |
Sunquest Information Systems 4801 Broadway Boulevard Tucson, AZ 85711 | Flexilab Blood Bank and Blood Donor, Version 5.2 | BK990002 | 08/16/1999 |
Sunquest Information Systems, Inc 4801 Broadway Boulevard Tucson, AZ 85711 | FlexiLab Blood Bank and Blood Donor System, version 5.2 | BK990034 | 11/17/1999 |
Systec Computer Associates, Inc 28 North Country Road Mt. Sinai, NY 11766 | LifeTec Elite 1.0 | BK060032 | 08/21/2006 |
Systec Computer Associates, Inc 28 North Country Road Mt. Sinai, NY 11766 | LifeTec Donor Verification and Collection System (DOVAC) 1.00 | BK040026 | 10/21/2004 |
Systec Computer Associates, Inc 28 North Country Road Mt. Sinai, NY 11766 | LifeTec, Version 2.20 | BK990003 | 07/30/1999 |
SysTec Computer Associates 28 North Country Road Mt. Sinai, NY 11766 | LifeTec Community Blood Center System Revision 2.10 | BK960034 | 07/28/1998 |
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Talisman Ltd 421 Church Street NE. Suite F Vienna, VA 22180 | Quality Donor System v2.1 | BK070020 | 07/16/2007 |
Talisman Ltd 421 Church Street NE. Suite F Vienna, VA 22180 | Talisman Phlebotomy System, Release 1.0 | BK060031 | 07/27/2006 |
Talisman Ltd 421 Church Street NE. Suite F Vienna, VA 22180 | Quality Donor System 2004 2.0 | BK040062 | 10/18/2004 |
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Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills, CA 95762 | Component Manufacturing Interface for ElDorado Donor | BK100002 | 02/01/2010 |
Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills, CA 95762 | ElDorodo Donor Doc | BK090033 | 10/28/2009 |
Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills, CA 95762 | Test Result Interface for ElDorado Donor | BK090063 | 11/20/2009 |
Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills, CA 95762 | ElDorado Donor 1.0.0 | BK070064 | 02/13/2008 |
Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills CA 95762 | ElDorado Donor Doc 1.0.0 | BK070010 | 05/23/2007 |
Wyndgate Technologies 11121 Sun Center Drive, Suite C Rancho Cordova, CA 95670 | Safe Trace Version 1.0 | BK950059 | 04/14/1997 |
Wyndgate Technologies 111212 Sun Center Drive, Suite C Rancho Cordova, CA 95670 | SafeTrace TX, Version 1.0 | BK980023 | 01/29/1999 |
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ZLB Behring AG Wankdorfstrasse 10 Bern, Switzerland | System for Plasma Identification (SPI) 2.0.0 | BK050078 | 12/22/2005 |
ZLB Bioplasma AG Wannkdorfstrasse 10 Bern, Switzerland | System for Plasma Identififcation (SPI) 1.0 | BK020020 | 10/30/2002 |
Back to Alphabetical Index |
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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