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Premarket Approval Information - Devices

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Applicant: OraSure Technologies, Inc, Bethlehem, PA
Product: OraQuick Rapid HIV-1 Antibody Test
PMA number: BP010047
Indication for Use: Detection of HIV-1 antibodies in fingerstick whole blood specimens
Approval Date: 11/7/2002

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Updated April 4, 2003
 
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