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Vaccines, Blood & Biologics

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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

Label (PDF - 763 KB)

Summary (PDF - 109 KB)

Control Kit (PDF - 130 KB)

Subject Information (PDF - 257 KB)

    
 

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  • Consumer Affairs Branch (CBER)

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    Food and Drug Administration

    1401 Rockville Pike

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    Rockville, MD 20852-1448

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