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In this section: Approved Blood Products

OraQuick Rapid HIV-1/2 Antibody Test

Applicant: OraSure Technologies, Bethlehem, PA
Product: OraQuick Rapid HIV-1/2 Antibody Test
PMA number: BP010047
Indication for Use: Allow for an added labeling claim for the detection of antibodies to HIV-1 and HIV-2 in plasma specimens and the detection of HIV-1 antibodies in oral fluid specimen.

Product Information

Package Insert - OraQuick Rapid HIV-1/2 Antibody Test

Supporting Documents

Supporting Documents older than three years - OraQuick Rapid HIV-1/2 Antibody Test

Resources For You

Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents

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