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In this section: Approved Blood Products

OraQuick HIV Self-Test

PMA: BP120001
Proper Name: OraQuick HIV Self-Test
Tradename: None
Manufacturer: OraSure Technologies, Inc.
Indications:

The OraQuick HIV Self-Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human oral fluid specimens. The OraQuick® HIV Self-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. It is not intended to be used with specimens other than oral fluid.

Product Information

Package Insert - OraQuick HIV Self-Test

Supporting Documents

Related Information

Information regarding the OraQuick In-Home HIV Test

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