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In this section: Approved Blood Products

OraQuick Rapid HIV-1 Antibody Test

Applicant: OraSure Technologies, Inc, Bethlehem, PA
Product: OraQuick Rapid HIV-1 Antibody Test
PMA number: BP010047
Approval Date: 9/5/2003
Indication for Use:

Allow for a labeling claim for the detection of antibodies to HIV-1 in venipuncture whole blood specimens and to reduce the maximum read time from 60 minutes to 40 minutes.

Product Information

Label - OraQuick Rapid HIV-1 Antibody Test

Supporting Documents

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

Related Information

OraQuick Rapid HIV-1 Antibody Test Questions and Answers - ARCHIVED

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