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U.S. Department of Health and Human Services

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OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

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 (marketing approval)

Label (PDF - 763 KB)

Summary (PDF - 109 KB)

Control Kit (PDF - 130 KB)

Subject Information (PDF - 257 KB)
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