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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Supporting Documents
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.
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Related Information
Information regarding the OraQuick In-Home HIV Test - Press Release: FDA approves first over-the-counter home use rapid HIV test kit
7/3/2012 FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
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