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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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GS HIV Combo Ag/Ab EIA

PMA: BP100064
Proper Name: GS HIV Combo Ag/Ab EIA
Manufacturer: Bio-Rad Laboratories
Indication: as an aid in the diagnosis of HIV infection, including in pediatric populations (children as young as two years old).
Approval Date: July 22, 2011


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002