OraQuick HIV Self-Test

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

• This test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid specimens for consumer use. The OraQuick HIV Self-Test kit is intended for over-the-counter use with the tester collecting the sample and performing all assay steps. The device is approved for use in individuals ages 14 and older.

Product Information

• Package Insert - OraQuick HIV Self-Test 

Supporting Documents

• September 15, 2026 Approval Order - OraQuick HIV Self-Test
• December 16, 2024 Approval Order - OraQuick HIV Self-Test
• Supporting Documents older than three years - OraQuick In-Home HIV Test

Related Information

• Information regarding the OraQuick In-Home HIV Test