| Specifications | Issued February 7, 2012 Currently Approved CBER Device Premarket Applications \PMAs\ - updated 1/31/12 Currently Approved CBER Device Premarket Applications \PMAs\ CBER |
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| Specifications | Issued February 7, 2012 Currently Approved CBER Device Premarket Applications \PMAs\ - updated 1/31/12 Currently Approved CBER Device Premarket Applications \PMAs\ CBER |
| Business section |
| Specifications | Issued February 7, 2012 Currently Approved CBER Device Premarket Applications \PMAs\ - updated 1/31/12 Currently Approved CBER Device Premarket Applications \PMAs\ CBER |
| Suggested Link Details/Purchase | |
| Content | Currently Approved CBER Device Premarket Applications (PMAs) As of February 01, 2012 Sorted by Applicant Name 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 BP090080 Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064-3500 Trade Name: ARCHITECT HIV Ag/Ab Combo Assay Approved Date: 18-JUN-2010 BP090022 Avioq, Inc. 9700 Great Seneca Hwy. Rockville, MD 20850 Trade Name: Avioq HIV-1 Microelisa System Approved Date: 21-SEP-2009 BP090032 bioLytical Laboratories, Inc 1108-13351 Commerce Parkway Richmond, BC, British Columbia Canada V6V 2X7 Trade Name: INSTI™ HIV-1 Antibody Test Kit Approved Date: 29-NOV-2010 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 BP100064 Bio-Rad Laboratories 6565 185th Avenue NE Redmond, WA 98052 Trade Name: GS HIV Combo Ag/Ab EIA Approved Date: 22-JUL-2011 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 |
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| Following Datasheets | UCM149972_1 (12 pages) UCM149975_1 (125 pages) UCM152828_1 (6 pages) UCM163159_1 (1 pages) UCM163919_1 (1 pages) UCM171764_1 (5 pages) UCM173430 (2 pages) UCM188476_1 (4 pages) UCM189544 (7 pages) UCM190609_1 (15 pages) |
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