Premarket Approval Information - Devices
Applicant: OraSure Technologies, Bethlehem, PA
Product: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
PMA number: BP010047 / 16
Indication for Use: Added labeling claim for the detection of HIV-2 antibodies in oral fluid and a change in the name of the device to OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
Approval Date: 6/22/2004
Letter -
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Label -
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Summary -
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Control Kit -
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Subject Information -
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