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U.S. Department of Health and Human Services

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 

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
Back to Alphabetical Index
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
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
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
Back to Alphabetical Index
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
CSL Behring AG
Wankdorfstrasse 10
3014 Bern
Switzerland
System for Plasma Identification (SPI), version 3.1.0BK11002306/08/2011
Back to Alphabetical Index
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
Back to Alphabetical Index
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
Back to Alphabetical Index
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 2.0
 
BK11002508/22/2011
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, 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
Back to Alphabetical Index
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
Back to Alphabetical Index
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 II® Version 25   BK09001706/23/2009
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
SoftDonor® Version 4.5   BK08006901/16/2009
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 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
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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
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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
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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
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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