Premarket Approval Information - Devices
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
Letter
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Label (PDF)
Summary (PDF)
Talkpaper
Frequently Asked Questions (FAQs)
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