Premarket Approval Information - Devices
Applicant: OraSure Technologies, Bethlehem, PA
Product: OraQuick Rapid HIV-1/2 Antibody Test
PMA number: BP010047/10
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
Approval Date: 3/26/2004
Letter -
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Label -
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Control Kit -
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Subject Information -
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