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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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OraQuick Rapid HIV-1/2 Antibody Test

Applicant: OraSure Technologies, Bethlehem, PA
Product: OraQuick Rapid HIV-1/2 Antibody Test
PMA number: BP010047

Package Insert (PDF - 763 KB)


Approval Date: 3/26/2004

PMA number: BP010047/10

Indication for Use: Allow for an added labeling claim for the detection of antibodies to HIV-1 and HIV-2 in plasma specimens and the detection of HIV-1 antibodies in oral fluid specimen.

March 26, 2004 Approval Letter

Control Kit (PDF - 130 KB)

Subject Information (PDF - 257 KB)

 

Approval Date: 3/19/2004

PMA number: BP010047/12
Indication for Use: Addition to the intended use statement to include detection of antibodies to HIV-2.

March 19, 2004 Approval Letter

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448