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
 
Updated: September 5, 2008