PMA: BP910001
Proper Name: OraSure HIV-1 Oral Specimen Collection Device
Tradename: None
Manufacturer: OraSure Technologies, Inc.
Indications:

• OraSure HIV-1 Oral Specimen Collection Device is intended for use in the collection of oral fluid specimens by properly trained individuals for the purpose of testing for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1).
• OraSure HIV-1 specimens are intended to be used only with the Avioq HIV-1 Microelisa System screening test manufactured by Avioq, Inc. OraSure HIV-1 is intended for use with subjects 13 years of age or older.

Product Information

• Package Insert - OraSure HIV-1 Oral Specimen Collection Device

Supporting Documents

• February 23, 2022 Approval Order - OraSure HIV-1 Oral Specimen Collection Device