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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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OraQuick In-Home HIV Test

PMA:  BP120001
Proper Name:  OraQuick In-Home HIV Test
Tradename: None
Manufacturer: OraSure Technologies, Inc.
Indications: The OraQuick® In-Home HIV Test is an in-vitro diagnostic home-use test for HIV (HIV-1 and HIV-2) in oral fluid. This test works by looking for your body’s response (antibodies) to fighting the HIV virus. A positive result is preliminary and follow-up confirmatory testing is needed. 
Approval Date: July 3, 2012 

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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