Approved Premarket Approval (PMA) Device Applications
Alphabetical Listing by Applicant Name
Information updated through March 31, 2009
BP060002 ABBOTT Molecular, Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018
Trade Name: Abbott RealTime HIV-1
Amplification Reagent Kit
Abbott RealTime HIV-1 Calibrator
Kit
Abbott RealTime HIV-1 Control Kit
Approved Date: 11-MAY-2007
BP830014 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Trade Name: Corzyme-M
Approved Date: 21-DEC-1983
BP900002 Abbott Laboratories
Abbott Park
Buckley Road and Waukegan Road
North Chicago, IL 60064
Trade Name: IMx Core-M Assay
Approved Date: 20-MAR-1991
BP850001 Baxter Healthcare Corporation
Route 120 & Wilson Road
Round Lake, IL 60073
Trade Name: Autopheresis-C Plasmapheresis
System
Approved Date: 24-MAR-1986
BP970001 Baxter Healthcare Corporation
9 Parker
Irvine, CA 92618
Trade Name: Isolex 300 Magnetic Cell
Separation System
Approved Date: 02-JUL-1999
BP040046 Bio-Rad Laboratories
6565 185th Avenue NE
Redmond, WA 98052
Trade Name: Multispot HIV-1/HIV-2 Rapid Test
Approved Date: 12-NOV-2004
BP010001 BioMerieux, Inc.
100 Akzo Avenue
Durham, NC 27712
Trade Name: HIV-1 NucliSens QT
Approved Date: 19-NOV-2001
BP020066 BioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712
Trade Name: Vironostika HIV-1 Plus O
Microelisa System
Approved Date: 06-JUN-2003
BP050009 Chembio Diagnostic Systems, Inc.
3661 Horseblock Road
Medford, NY 11763
Trade Name: Chembio HIV Reactive/Nonreactive
Controls
SURE CHECK HIV 1/2 ASSAY
Approved Date: 25-MAY-2006
BP050010 Chembio Diagnostic Systems, Inc.
3661 Horseblock Road
Medford, NY 11763
Trade Name: Chembio HIV Reactive/Nonreactive
Controls
HIV 1/2 STAT-PAK ASSAY
Approved Date: 25-MAY-2006
BP860017 Connaught Laboratories Limited
1755 Steeles Avenue West
Willowdale, Canada
Trade Name: Microplate Anti-HBc EIA
Approved Date: 30-DEC-1987
BP860031 DiaSorin, Inc.
1990 Industrial Blvd.
Stillwater, MN 55082
Trade Name: Micro trak II Igm Anti-HBCore EIA
Approved Date: 13-JUN-1993
BP950002 Home Access Health Corporation
2401 West Hassell Road
Suite 1510
Hoffman Estates, IL 60195-5200
Trade Name: Home Access HIV-1 Test System
Approved Date: 22-JUL-1996
BP000009 Maxim Biomedical Inc
1440 Fourth Street
Berkeley, CA 94710
Trade Name: Calypte HIV-1 Urine EIA
Approved Date: 12-JAN-2001
Approved Under Calypte Biomedical
Corporation
BP010009 Maxim Biomedical Inc
1265 Harbor Bay Parkway
Alameda, CA 94502
Trade Name: Cambridge Biotech HIV-1 Urine
Western Blot
Approved Date: 21-JUN-2001
Approved Under Calypte Biomedical
Corporation
BP000023 MedMira Labs
155 Chain Lake Drive, Bayers Lake
Halifax, Nova Scotia Canada B3S 1B3
Trade Name: MedMira Rapid HIV Test
Approved Date: 16-APR-2003
BP910001 OraSure Technologies
8505 SW Creekside Place
Beaverton, OR 97005
Trade Name: Orasure HIV-1 Oral Specimen
Collection Device
Approved Date: 23-DEC-1994
BP950004 OraSure Technologies
220 East First Street
Bethlehem, PA 18015-1360
Trade Name: OraSure HIV-1 Western Blot Kit
Approved Date: 03-JUN-1996
Approved Under Epitope, Inc.
BP010047 OraSure Technologies
150 Webster Street
Bethlehem, PA 18015-1389
Trade Name: OraQuick ADVANCE Rapid HIV-1/2
Antibody Test
Approved Date: 07-NOV-2002
BP870003 Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
Trade Name: ORTHO HBc Antibody ELISA Test
System
Approved Date: 17-APR-1987
BP050051 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626-5101
Trade Name: VITROS Immunodiagnostics Products
Anti-HIV 1+2 Calibrator
VITROS Immunodiagnostics Products
Anti-HIV 1+2 Reagent Pack
Approved Date: 27-MAR-2008
BP950005 Roche Molecular Systems, Inc.
1080 US Highway 202
Branchburg,, NJ 08876-3771
Trade Name: Roche Amplicor HIV-1 Monitor (tm)
Test
Approved Date: 03-JUN-1996
BP050069 Roche Molecular Systems, Inc.
4300 Hacienda Drive
P.O. Box 9002
Pleasanton,, CA 94588-0900
Trade Name: COBAS AmpliPrep/COBAS TaqMan HIV-1
Test, 48 Tests
COBAS AmpliPrep/COBAS TaqMan Wash
Reagent, 5.1 L
Approved Date: 11-MAY-2007
BP000028 Siemens Medical Solutions Diagnostics
P.O. Box 2466
Berkeley, CA 94702-0466
Trade Name: Quntiplex HIV-1 RNA 3.0 Assay
(bDNA)
Approved Date: 11-SEP-2002
Approved Under Bayer Corporation
BP050030 Siemens Medical Solutions Diagnostics
511 Benedict Ave.
Tarrytown, NY 10591
Trade Name: ADVIA Centaur HIV 1/O/2 Enhanced
ReadyPack Reagents
Approved Date: 18-MAY-2006
Approved Under Bayer HealthCare
BP060001 Thermogenesis
2711 Citrus Road
Rancho Cordova, CA 95742
Trade Name: CryoSeal FS System
Approved Date: 26-JUL-2007
BP030025 Trinity Biotech plc
IDA Business Park
Southern Cross Road
, Bray, Co. Wicklow Ireland
Trade Name: Uni-Gold Recombigen HIV-1
Approved Date: 23-DEC-2003