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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448