Vaccines, Blood & Biologics

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 

ApplicantDevice Name510(k) NumberClearance Date
A
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064
Abbott Apheresis Tracking System (AARTS) Version 1.0BK95004806/24/1998
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064
Abbott DMS II Version 1.5BK95005208/12/1998
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064
Abbott DMS Version 3.0.2BK95003208/18/1998
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Abbott Prism RetestBK01003607/17/2002
ADAC HealthCare Information System
5 Greenway Plaza, Suite 1900
Houston, TX 77046
LabCare Blood Bank II Version 13.3BK96002708/12/1998
American Blood Resources Association
PO Box 669
Annapolis, MD 21404
National Donor Deferral Registry Version 2.0BK96003003/20/1997
American Blood Resources Association
147 Old Solomons Island Road
Annapolis, MD 21401
National Donor Deferral Registry Ver 1.0BK01001209/06/2001
American Red Cross
Washington, DC 20006
National Biomedical Computer System, Version 1.1BK96004002/28/1997
American Red Cross Blood Services
Arlington, VA 22209
NGTL Automation system (NAS) 5.2.0BK02003203/20/2003
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B
Bayer Corp
800 Dwight Way
Berkeley, CA 94701
Plasma Procurement Information System Version 2.0BK96005108/07/1998
Bayer Corp
800 Dwight Way
Berkeley, CA 94701
Plasma Procurement Information System (PPIS), version 3.0BK99002411/03/1999
Bayer Corp
800 Dwight Way
Berkeley, CA 94701
Plasma Procurement Information System (PPIS), version 4.0BK99003711/17/1999
Baxter Healthcare Corp
550 North Brand Blvd
Glendale, CA 91203
Serology SQL LIMS 1.0BK02000208/07/2002
BBK Technology LLC
2910 E. Highland Ave.
Phoenix, AZ 85016
RC-AID, version 2.0BK10003709/13/2010
Becton, Dickinson & Company
1 Becton Drive, MC 300
Franklin Lakes, NJ 07417-1885
Bd.id Patient Identification System for Transfusion Management V7.00BK06004602/13/2007
BioLife Plasma Services LP
One Baxter Parkway
Deerfield IL 60015
Donor Information System (DIS) v7.0BK14016410/20/2014
BioLife Plasma Services LP
One Baxter Parkway
Deerfield IL 60015
Automated Plasma Dispositioning System (APDS) v1.0BK12006905/31/2013
BioLife Plasma Services LP
One Baxter Parkway
Deerfield IL 60015
Donor Information System (DIS) v6.0BK12006412/19/2012
BioLife Plasma Services LP
One Baxter Parkway
Deerfield IL 60015
Donor Information System (DIS) version 4.0BK09000108/18/2009
BioLife Plasma Services LP
One Baxter Parkway
Deerfield IL 60015
Donor Information System v3.3BK08001607/02/2008
BioLife Plasma Services LP
One Baxter Parkway
Deerfield IL 60015
Donor Information System (DIS) 3.2 BK06001705/09/2006
BioLife Plasma Services LP
One Baxter Parkway
Deerfield IL, 60015
Donor Information System (DIS) 3.1BK05002907/07/2005
Biomat USA, Inc.
13111 Temple Avenue
City of Industry, CA  91746
System for Plasma Identification (SPI), Version 2.0.0BK09008210/01/2010
Biosafe SA
Route du Petit Eysins 1
1262 Eysins (Vaud)
Switzerland
Sepax Cell Separation System and Single-Use Kits, Sepax 2 S-100BK11002210/28/2011
Blood Bank Computer Systems, Inc
1002 15th SW, Suite 120
Auburn, WA 98001-6502
ABO QuickPass, version 1.0.0BK14013010/10/2014
Blood Bank Computer Systems, Inc
1002 15th SW, Suite 120
Auburn, WA 98001-6502
BBCS Primary Application, version 5.4.3BK14014210/10/2014
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
BK12002806/21/2012
Blood Bank Computer Systems, Inc
1002 15th SW, Suite 120
Auburn, WA 98001-6502
BBCS Hospital Interface Application (BBCSH), H 1.0.0BK09008112/23/2009
Blood Bank Computer Systems, Inc
1002 15th SW, Suite 120
Auburn, WA 98001-6502
BBCS Mobile Application 5.0MBK05001306/01/2005
Blood Bank Computer Systems, Inc
1002 15th SW, Suite 120
Auburn, WA 98001-6502
BBCS Lab Interface Application (BBCS Lab) 5.0LBK04008702/15/2005
Blood Bank Computer Systems, Inc
1002 15th SW, Suite 120
Auburn, WA 98001-6502
Blood Bank Control System (BBCS) 5.0BK04005610/22/2004
Blood Bank Computer Systems, Inc
1501 West Valley Hwy, Suite 101
Auburn, WA 98001
Blood Bank Control System Version 4.0/4.1/4.2/4.3BK96004410/15/1997
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C
Calimex USA Corporation
258 Hollister Ave
Alameda, CA 94501
eOrders, Version 1BK11007002/17/2012
Calimex USA Corporation
258 Hollister Ave
Alameda, CA 94501
Picture-IDBK09005401/11/2010
Care Fusion, Inc.
1430 Spring Hill Road, Suite 510
McLean, VA 22102
wBlood Care 1.0BK04000211/10/2004
CaridianBCT, Inc.
10811 W. Collins Ave.
Lakewood, CO 80215
Trima Accel Automated Blood Component Collection SystemBK11005112/20/2011
Carter BloodCare
2205 Highway 121
Bedford, TX 76021
LifeTrak / Distribution, version 2.03BK99001510/22/1999
Carter BloodCare
2205 Highway 121
Bedford, TX 76021
LifeTrak / Donor, version 2.03BK99002712/15/1999
Cerner Corp
2800 Rockcreek Parkway
Kansas City, MO 64117
PathNet Blood Bank Center Version 306BK95005107/16/1997
Cerner Corp
2800 Rockcreek Parkway
Kansas City, MO 64117
PathNet Blood Bank Transfusion Version 306BK95005307/16/1997
Cerner Corp
2800 Rockcreek Parkway
Kansas City, MO 64117
PathNet Blood Bank Donor Version 306BK95005507/16/1997
Cerner Corp
2800 Rockcreek Parkway
Kansas City, MO 64117
PathNet Worksystems Blood Bank Transfusion Version 306BK96002407/16/1997
Cerner Corp
2800 Rock Creek Parkway
Kansas City, MO 64117
HNA Millennium PathNet Blood Bank TransfusionBK99000711/02/1999
Cerner Corp
2800 Rock Creek Parkway
Kansas City, MO 64117
Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01BK03002808/19/2003
Cerner Corp
2800 Rock Creek Parkway
Kansas City, MO 64117
Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.3BK06003705/24/2007
Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
Chiron Procleix NAT Tracker 3.0 BK06000503/01/2006
Community Bio-Resources, Inc
2197 Parkway Lake Drive
Hoover, AL 35244
Donor Information System Version 1.0BK97000704/09/1997
Community Blood Centers of South Florida
1700 North State Road 7
Lauderhill, FL 33313
Regulated Software Application (RSA)BK11004801/12/2012
Community Blood Center of Greater Kansas City
4040 Main Street
Kansas City, MO 64117
CBC Blood System Version 1.2BK96006011/20/1997
Computer Programs and Systems, Inc.
6600 Wall Street
Mobile, AL 36695
Blood Administration, version 1900BK13000304/30/2014
CSL Behring AG
Wankdorfstrasse 10
3014 Bern
Switzerland
System for Plasma Identification (SPI), version 3.1.0BK11002306/08/2011
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D
Data Innovations, Inc.
120 Kimball Ave., Suite 100
South Burlington, VT 05430
Instrument Manager v8. 12BK12005110/17/2012
Data Innovations, Inc.
120 Kimball Ave., Suite 100
South Burlington, VT 05430
Instrument Manager v8.10BK10004608/12/2010
Data Innovations, Inc.
120 Kimball Ave., Suite 100
South Burlington, VT 05430
Instrument Manager 8.05.01.10BK06005301/05/2007
Data Innovations, Inc.
120 Kimball Ave., Suite 100
South Burlington, VT 05430
imExpress 7.2.5BK02005707/29/2003
Department of Defense
5205 Leesburg Pike
Suite 1000
Falls Church VA  22041
Defense Blood Standard System (DBSS) 10.0.0BK07003505/22/2008
Department of Defense
5 Skyline Plaza
Falls Church, VA 22047
Defense Blood Standard System Versions 1.00/1.03BK96000408/01/1997
Department of Defense
5113 Leesburg Pike, Suite 701
Falls Church, VA 22041
Defense Blood Standard System Version 3.00BK98003108/31/1998
Department Of Veterans Affairs
P.O. Box 7008
Hines, IL 60141-7008
VistA Blood Establishment Computer Software (VBECS) 1.0BK06004310/19/2006
Department Of Veterans Affairs
P.O. Box 5000
VA Hines Medical Center
Hines, IL 60141
Vista Blood Bank, Version 5.2BK97002104/23/1999
Digi-Trax
1550 Barclay Blvd
Buffalo Grove, IL 60089
Donor - ID Version 1.0BK97001302/27/1998
Digi-Trax
1550 Barclay Blvd
Buffalo Grove, IL 60089
Digi-Trax Donor-ID Version 2.0BK00002004/20/2000
Digi-Trax
1550 Barclay Blvd
Buffalo Grove, IL 60089
Donor-ID 2.2BK01004904/26/2002
Duley Hopkins and Associates
1200 Mountain Creek Road
Chattanooga , TN 37405
Blood Bank Information Management System (BBIMS) v2.05.01BK09007901/13/2010
Duley Hopkins and Associates
1200 Mountain Creek Road
Chattanooga , TN 37405
Blood Bank Information Management System (BBIMS)BK07006504/25/2008
Dynamic Healthcare Techonologies, Inc
101 Southhall Lane, Suite 210
Maitland, FL 32751
Transfusion Service Manager Version 4.1.6BK96004112/16/1997
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E
Eclipsys Corporation
450 Lapp Road
Malvern, PA 19355
Sunrise Blood Bank, version 2.0 SP2BK09004411/13/2009
Epic Systems Corporation
1979 Milky Way
Verona, WI 53593
Blood Product Administration Module, version 0.9BK13003703/06/2014
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F
Fenwal Inc.
Three Corporate Drive
Lake Zurich, IL 60047
AMICUS Separator System with Software Version 4.3BK11003012/23/2011
Fenwal Inc.
Three Corporate Drive
Lake Zurich, IL 60047
Fenwal DXT Relay, Software Version 2.0BK11002508/22/2011
Fenwal Inc.
Three Corporate Drive
Lake Zurich, IL 60047
AMICUS® Separator: Software 3.1 with EDI ExportBK08004810/02/2008
Fifth Dimension Information Systems
Suite 500, 10025- 102A Avenue
Edmonton, Alberta T5J 2Z2
CANADA
E-Interview (eQue) 1.0.0BK05006005/24/2006
Fifth Dimension Information Systems
Suite 500, 10025- 102A Avenue
Edmonton, Alberta T5J 2Z2
CANADA
LOGIC 2.0BK04004010/06/2004
Fifth Dimension Information Systems
Suite 500
Midland Walwyn Tower
Edmonton Centre
Edmonton, Alberta
Canada T5J2Z2
Plasma Center Module, Version 1.0BK98002505/18/1999
Fifth Dimension Information Systems
Suite 500 Merril Lynch Tower
Edmonton Centre
Edmonton, Canada
Donor Management System, version 1.0.0BK99002209/10/1999
Fifth Dimension Information Systems
Suite 500
Edmonton, Alberta
Cananda T5J2Z2
P2K Plasma Center Module 2000 Version 1.0BK00002606/22/2000
Fifth Dimension Information Systems
Suite 500, Merril Lynch Tower
Edmonton Centre
Edmonton, Alberta, T5J 2Z2
CANADA
LOGIC 1.0BK02005802/03/2003
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G
Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
Vista Information System, Version 3.0 with Medical Review ModuleBK07006612/13/2007
Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
Vista Information System, Independent SolutionBK02001507/15/2002
Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498
Vista Information System 2.1BK03002105/01/2003
GE Medical Information Technologies
540 Northwest Highway
Barrington, IL 60010
Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0BK05001806/13/2005
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H
Haemonetics Software Solutions
4925 Robert J Mathews Pkwy., Suite 100
El Dorado Hills, CA 95762
Cross Donation Check System (CDCS) 1.0.0BK14016610/10/2014
Haemonetics Software Solutions
4925 Robert J Mathews Pkwy., Suite 100
El Dorado Hills, CA 95762
NextGen v2.0.0BK13008208/08/2014
Haemonetics Software Solutions
4925 Robert J Mathews Pkwy., Suite 100
El Dorado Hills, CA 95762, USA
Phlebotomy System version 1.0.0BK12008404/30/2013
Haemonetics Corporation
10025 102A Avenue, Suite 500
Edmonton, Alberta, Canada T5J 2Z2
LOGIC Version 3.0.0BK12000204/24/2012
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
Nextgen, version 1.0.0BK11001506/13/2011
Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
Symphony System 3.0BK09004109/28/2009
Healthcare-ID
1635 Barclay Blvd
Buffalo Grove IL 60089
Donor-ID™ Web Version 3.2 integrated with biometric finger identification technology, optionalBK12003006/25/2012
Healthcare-ID
1635 Barclay Blvd
Buffalo Grove IL 60089
Donor-ID Web™, version 3.1.4BK08004406/10/2009
Healthcare-ID
1635 Barclay Blvd
Buffalo Grove IL 60089
Donor-ID 3.0BK06005802/08/2007
Healthcare-ID
1635 Barclay Blvd.
Buffalo Grove, IL 60089
Donor-ID version 2.5BK03004910/31/2003
Healthcare Management Systems, Inc
3102 West End Avenue, Suite 400
Nashville, TN 37203
Monitor Blood Administration Module Release 24.0BK05000109/28/2005
Healthcare Management Systems, Inc.
3102 West End Ave., Suite 400
Nashville, TN 37203
HMS Blood Administration Module, Release 8.0BK09002503/04/2010
Helmer Labs, Inc
15425 Herriman Boulevard
Noblesville, IN 46060
UltraCW (with Software version 3.13)BK02002910/04/2002
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I
Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071
ImmuLINK, version 2.0BK12001606/14/2012
Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071
Galileo NeoTM Automated Blood Bank SystemBK10003308/23/2010
lmmunetics, Inc.
27 Drydock Avenue
Boston, MA 02210
BacTx® Bacterial Detection Kit for PlateletsBK11005406/11/2012
Information Data Management, Inc
9701 West Higgins Rd
Rosemont, IL 60018
IDM Symphony System 2.0BK07003112/13/2007
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
IDM Surround system 3.0BK01002808/30/2001
Information Data Management, Inc
9701 West Higgins Rd
Rosemont, IL 60018
Components and Distribution Information System Version 1.0BK95003708/26/1996
Information Data Management, Inc
9701 West Higgins Rd
Rosemont, IL 60018
Donor Mgmt. Information System Version 1.2BK95004508/26/1996
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
Plasma Center Management System Version 1.0BK98002007/31/1998
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
Plasma Center Management System Version 1.1BK98002809/04/1998
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
Surround System 1.0BK99001608/27/1999
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
Plasma Center Management System (PCMS), Version 1.2BK99002910/13/1999
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
Plasma Center Management System (PCMS), Version 2.0BK99004601/06/2000
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
Surround System 2.0BK00001604/07/2000
Information Data Management Systems, Inc
9701 west Higgins Road
Rosemont, IL 60018
Surround System, Version 3.2BK02003810/08/2002
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018
IDM Prelude System, Version 1.1BK05001407/18/2005
Informedics, Inc
4000 Kruse Way Place, Building 3
Lake Oswego, OR 97035
Lifeline Blood Bank Management System Release 4.2BK95006407/01/1998
IT Synergistics, LLC
115 Tree Street
Flowood, MS 39232
DoVac Elite v2.0BK14009104/09/2014
IT Synergistics, LLC
115 Tree Street
Flowood, MS 39232
DoVac Elite v1.0BK110064 09/06/2012
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K
Korchek Technologies, LLC
770 Plattsville Road
Trumbull, CT 06611
CareChek Patient Identification System, CareChek, Version 1.0BK04005308/12/2005
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L
Lattice, Inc.
1751 South Naperville Road
Wheaton, IL 60189
MediCopia Transfusion v4.1BK11005501/06/2012
Life Technologies Corporation
9099 North Deerbrook Trail
Brown Deer, WI  53223
Applied Biosystems 3500 Dx/3500xL Dx Genetic Analyzer CS2 & 3500 Dx Series Data Collection SoftwareBK11003902/05/2013
Life Technologies Corporation
9099 North Deerbrook Trail
Brown Deer, WI  53223
SeCore® HLA Sequencing System & uType® Dx HLA Sequence Analysis Software v 1.0BK11003802/05/2013
LifeSouth Community Blood Centers Inc.
4039 W. Newberry Road
Gainesville, FL 32607
Integrated Blood Bank Information SystemBK09006412/08/2009
LifeSouth Community Blood Centers Inc
4039 W. Newberry Road
Gainesville, FL 32607
Integrated Blood Bank Information System (IBBIS) Registration Module v1.0BK08001708/05/2008
LifeTrak/BloodCare
9000 Harry Hines Blvd.
Dallas, TX 75235
Lab Version 2.01BK94004810/01/1998
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M
MAK System SAS International Group
10 Avenue de la Grande Armee
Paris 75017
FRANCE
ePROGESA v5.0.1BK08000205/13/2008
MAK-System
10 Avenue de la Grande Armee
FRANCE
PROGESA 4.4hBK07006210/26/2007
MAK System
10 Avenue de la Grande Armee
Paris, France
Patient Health Software 1.0BK06003505/09/2007
MAK System
Z.1. Paris Nord II
13, Rue de la Perdix
B.P. 50035
95946 Roissy C.D.G. CEDEX, France
Progesa, Version 4.4aBK96005012/10/1998
Medical Information Technology
Meditech Circle
Westwood, MA 02090
Meditech Magic Blood Bank, Version 4.5/4.6BK96002903/19/1999
Medical Information Technology
Meditech Circle
Westwood, MA 02090
Magic Client Server, Version 5.1BK98004602/08/2000
MEDITECH Medical Information Technology, Inc.
MEDITECH Circle
Westwood, MA 02090
MEDITECH Client Server Blood Bank module v5.6BK08003710/30/2008
Mediware Information Systems, Inc.
1900 Spring Road, Suite 450
Oak Brook, IL 60523 
HCLLTM Transfusion 2012BK12003609/12/2012
Mediware Information Systems, Inc.
1900 Spring Road, Suite 450
Oak Brook, IL 60523 
LifeTrak® Version 2012BK120039 09/05/2012
Mediware Information Systems, Inc.
1900 Spring Road, Suite 450
Oak Brook, IL 60523
LifeTrak®/ Plasma, Version 1.0.0BK10006903/04/2011
Mediware Information Systems, Inc.,
11711 West 79th Street
Lenexa, KS 66214
LifeTrak®/ Lab and Distribution, Version 4.6.0BK100057 11/16/2010
Mediware Information Systems, Inc.,
11711 West 79th Street
Lenexa, KS 66214
LifeTrak®/Donor, Version 4.6.0BK10004310/21/2010
Mediware Information Systems, Inc.
Lenexa, KS 66214
HCLLTM Donor, version 2.0BK08006112/02/2008
Mediware Information Systems, Inc.
1900 Spring Road, Suite 450
Oak Brook Service Center
Oak Brook, IL 60523
HCLL Transfusion, v3.0BK08004910/22/2008
Mediware Information Systems, Inc
4545 Fuller Drive, Ste 320
Irving, TX 75038
LifeTrak / Donor 3.01BK06001906/21/2006
Mediware Information Systems, Inc
4545 Fuller Drive, Ste 320
Irving, TX 75038
HCLL Donor 1.0BK05001105/10/2005
Mediware Information Systems, Inc
4545 Fuller Drive, Ste 320
Irving, TX 75038
Instrument Interface Engine 1.0BK04004707/16/2004
Mediware Information Systems, Inc
4545 Fuller Drive, Ste 320
Irving, TX 75038
HCLL 2.6BK03007804/08/2004
Mediware Information Systems, Inc
9000 Harry Hines Blvd
Dallas, TX 75235
LifeTrak Lab 2.03BK01005206/17/2002
Mediware Information Systems, Inc
1121 Old Walt Whitman Road
Melville, NY 11747
Hemocare Blood Bank Management System Version 5.2BK98003412/10/1998
Mediware Information Systems, Inc
900 Oakmont Lane
Westmont, IL, 60659
Hemocare LifeLine Version, 1.0BK02004602/14/2003
Medserv, Inc
71 South Bedford Road
Mount Kisco, NY 10549
Plasmapheresis Data System III 1.0BK01003202/05/2002
Micro Typing Systems Inc.
Pompano Beach, FL
ORTHO ProVue ®, version 3.1 Patch 1 (V3.1.1)BK11002907/14/2011
Micro Typing Systems Inc.
Pompano Beach, FL
Ortho ProVue™, Software Version 3.1BK09001306/04/2009
Mississippi Blood Services, Inc.
1995 Lakeland Drive
Jackson, MS 39216
WebLab Online Laboratory System 2.0BK03006512/22/2003
Misys Healthcare Systems
4801 East Broadway Boulevard
Tucson, AZ 85711
Misys Laboratory Blood Bank and Blood Donor 6.0.1BK04006510/22/2004
Mosum Technology India PVT LTD
55 Northern Blvd, Suite 200
Great Neck, NY 11021
PowerBANK Enterprise Edition version 1.0BK06001403/30/2007
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N
Neoteric Technology Ltd
205-1099 W. 8th Ave.
Vancouver British Columbia V6H 1C3
CANADA
BloodTrack 4.1BK06004110/17/2006
Neoteric Technology Ltd
205-1099 W. 8th Ave.
Vancouver British Columbia V6H 1C3
CANADA
BloodTrack SafeTx Version 2.0BK05003208/16/2005
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O
Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
Raritan, NJ 08869-0606
ORTHO VERSEIA® Integrated Processor (VIP) as part of the ORTHO® Summit System (OSS)BK13000605/23/2013
Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
Raritan, NJ 08869-0606
ORTHO® Summit SystemBK11002606/28/2011
Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
Raritan, NJ 08869-0606
Ortho Verseia™ Pipetter as part of the Ortho Summit™ SystemBK09007405/29/2009
Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
Raritan, NJ 08869
Ortho Lab with Ortho Lab IC (Instrument Concentrator), Version 1.0BK99003004/03/2000
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P
Patient Safe™ Solutions, Inc.
5375 Mira Sorrento Place, Suite 500
San Diego, CA 92121
Patient Touch™ Blood Product Administration System v3.2.1BK12002911/13/2012
Prescott Ideas LLC
8960 E. Anna Place
Tucson, AZ 85710
Antibody Check 4.1BK06005604/23/2007
Psyche Systems Corp
Ten Laurel Avenue
Wellesley, MA 02481
System Blood Bank (SBB) Ver. 3.0BK01001709/04/2001
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R
Rubin & Poor, Inc
155 Maplewood Avenue #5
Maplewood, NJ 07040
Pool Results Manager Version 1.0C, Module for Roche NAT Testing Version 2.0ABK08002809/03/2008
Rubin & Poor, Inc
155 Maplewood Avenue #5
Maplewood, NJ 07040
Configurable Manual Batch Entry, Verion 1.1ABK03007301/14/2004
Rubin & Poor, Inc
155 Maplewood Avenue #5
Maplewood, NJ 07040
Configurable Laboratory Result Manager (CLRM) 1.0EBK00003011/23/2001
Rubin & Poor, Inc
150 West 25th Street, Suite 600
New York, NY 10001
Rubin & Poor Configurable Manual Blot System, version 1.0CBK99000810/29/1999
Rubin & Poor, Inc
155 Maplewood Avenue #5
Maplewood, NJ 07040
Chiron Procleix NAT Tracker 1.0EBK01002501/03/2002
Rowny Systems, Inc.
7555 Spring Lake Drive
Bethesda, MD 20817-6507
Antigen Plus Version 7.4BK11004505/25/2012
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S
Sanguin International
1020 Sherman Avenue
Hamden, CT 06514
Sanguin Liberty SRIMPORT 3.1BK10003007/08/2010
Sanguin International
1020 Sherman Avenue
Hamden, CT 06514
Sanguin Aurora version 2.0BK09006112/22/2009
Sanguin International
1020 Sherman Avenue
Hamden, CT 06514
Medussa 2000 Srimport, version 1.2BK98003906/11/1999
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
SoftBank version 25.5BK14012808/05/2014
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
SoftBank II® Version 25BK09001706/23/2009
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
SoftDonor® Version 4.5BK08006901/16/2009
SCC Soft Computer
5400 Tech Data Drive Clearwater, FL 33760
SoftBank II v23.2BK08002008/12/2008
SCC Soft Computer
34350 US Highway 19 North
Palm Harbor, FL 34684
SoftDonor 4.3 with SoftScape 1.2.0BK05004510/26/2005
SCC Soft Computer
5400 Tech Data Drive
Clearwater, FL  33760
SoftID.Tx Version 1.0BK09007812/03/2009
SCC Soft Computer, Inc.
5400 Tech Data Drive
Clearwater, FL 33760
SoftBank® II Version 25.1BK10004507/29/2010
Shared Medical Systems
51 Valley Stream Parkway
Malvern, PA 19355
SMS Blood Bank Transfusion System Versions 2.0/3.0/4.0BK96003612/12/1997
Siemens Healthcare Diagnostics, Inc.
P.O. Box 2466
Berkeley, CA 94702
TRUGENE® HIV-1 Genotyping Kit and OpenGene® DNA Sequencing SystemBK12001303/27/2012
Soft Computer Consultant
34350 US Highway 19 North
Palm Harbor, FL 34684
SoftBank II v23.1 with Database Management system Interface (DMSI)BK04004808/23/2004
Soft Computer Consultant
34350 US Highway 19 North
Palm Harbor, FL 34684
Softbank II Version 19.1BK96003307/10/1998
Soft Computer Consultants
34350 US Highway 19 North
Palm Harbor, FL 34684
Softbank II Version 21.1BK00004004/20/2001
Soft Computer Consultants, Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684
SoftBank II 22BK02002109/11/2002
Soft Computer Consultants, Inc
34350 U.S. Hwy 19 N
Palm Harbor, FL, 34684
SoftDonor 4.1BK02000602/27/2003
Soft Computer Consultants, Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684
SoftBank II 23BK03001804/17/2003
Soft Computer Consultants, Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684
SoftBank II version 23 with SoftScapeBK04002805/07/2004
Sunquest Information Systems
250 S. Williams Blvd.
Tucson, AZ 85711
Sunquest Transfusion Manager, version 2.0BK14012406/18/2014
Sunquest Information Systems
250 S. Williams Blvd.
Tucson, AZ 85711
Sunquest Blood Bank Donor 6.4BK08004203/03/2009
Sunquest Information Systems
250 S. Williams Blvd.
Tucson, AZ 85711
Sunquest Transfusion Manager v1.0BK08002112/03/2008
Sunquest Information Systems
4801 Broadway Boulevard
Tucson, AZ 85711
Flexilab Blood Bank and Blood Donor, Version 5.2BK99000208/16/1999
Sunquest Information Systems, Inc
4801 Broadway Boulevard
Tucson, AZ 85711
FlexiLab Blood Bank and Blood Donor System, version 5.2BK99003411/17/1999
SysLogic, Inc.
375 Bishops Way, Suite 105
Brookfield, WI
iTrace for Blood Centers, v 1.0.924.0BK12006705/28/2013
Systec Computer Associates, Inc
28 North Country Road
Mt. Sinai, NY 11766
LifeTec Elite 1.0BK06003208/21/2006
Systec Computer Associates, Inc
28 North Country Road
Mt. Sinai, NY 11766
LifeTec Donor Verification and Collection System (DOVAC) 1.00BK04002610/21/2004
Systec Computer Associates, Inc
28 North Country Road
Mt. Sinai, NY 11766
LifeTec, Version 2.20BK99000307/30/1999
SysTec Computer Associates
28 North Country Road
Mt. Sinai, NY 11766
LifeTec Community Blood Center System Revision 2.10BK96003407/28/1998
Back to Alphabetical Index
T
Talisman Ltd
421 Church Street NE. Suite F
Vienna, VA 22180
Quality Donor System v2.1BK07002007/16/2007
Talisman Ltd
421 Church Street NE. Suite F
Vienna, VA 22180
Talisman Phlebotomy System, Release 1.0BK06003107/27/2006
Talisman Ltd
421 Church Street NE. Suite F
Vienna, VA 22180
Quality Donor System 2004 2.0BK04006210/18/2004
Terumo BCT, Inc.
10811 West Collins Avenue
Lakewood, CO 80215-4498
Vista Information System, Version 3.2BK14010404/01/2014
Back to Alphabetical Index
W
Wyndgate Technologies
4925 Robert J. Matthews Parkway
Suite 100
El Dorado Hills, CA  95762
Component Manufacturing Interface for ElDorado DonorBK10000202/01/2010
Wyndgate Technologies
4925 Robert J. Matthews
Parkway
Suite 100
El Dorado Hills, CA 95762
ElDorodo Donor DocBK09003310/28/2009
Wyndgate Technologies
4925 Robert J. Matthews
Parkway
Suite 100
El Dorado Hills, CA 95762
Test Result Interface for ElDorado DonorBK09006311/20/2009
Wyndgate Technologies
4925 Robert J. Matthews Parkway
Suite 100
El Dorado Hills, CA 95762
ElDorado Donor 1.0.0BK07006402/13/2008
Wyndgate Technologies
4925 Robert J. Matthews Parkway
Suite 100
El Dorado Hills CA 95762
ElDorado Donor Doc 1.0.0BK07001005/23/2007
Wyndgate Technologies
11121 Sun Center Drive, Suite C
Rancho Cordova, CA 95670
Safe Trace Version 1.0BK95005904/14/1997
Wyndgate Technologies
111212 Sun Center Drive, Suite C
Rancho Cordova, CA 95670
SafeTrace TX, Version 1.0BK98002301/29/1999
Back to Alphabetical Index
Z
ZLB Behring AG
Wankdorfstrasse 10
Bern, Switzerland
System for Plasma Identification (SPI) 2.0.0BK05007812/22/2005
ZLB Bioplasma AG
Wannkdorfstrasse 10
Bern, Switzerland
System for Plasma Identififcation (SPI) 1.0BK02002010/30/2002
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

Page Last Updated: 10/27/2014
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