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

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Suite 200N/HFM-47

Rockville, MD 20852-1448