Approved Premarket Approval (PMA) Device Applications
Alphabetical Listing by Applicant Name
Information updated through August 31, 2008
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 94566-0990 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