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

Product Information

• Package Insert - OraQuick In-Home HIV Test

Supporting Documents

• Supporting Documents older than three years - OraQuick In-Home HIV Test

Related Information

• Information regarding the OraQuick In-Home HIV Test