Proper Name: OraQuick In-Home HIV Test
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
July 3, 2012 Approval Letter, OraQuick In-Home HIV Test Summary of Safety and Effectiveness, July 3, 2012 - OraQuick(PDF - 424KB)
The OraQuick® In-Home HIV Test is intended as an over-the-counter (OTC) test for consumer use as an aid in the diagnosis of infection with HIV-1 and HIV-2.
Information regarding the OraQuick In-Home HIV Test FDA Online Label Repository
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