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Vaccines, Blood & Biologics

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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 01/29/2015
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