Vaccines, Blood & Biologics

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

PMA number: BP010047/7
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.

September 5, 2003 Approval Letter

Package Insert (PDF - 1.81 MB)


Approval Date: 11/7/2002

PMA number: BP010047
Indication for Use: Detection of HIV-1 antibodies in fingerstick whole blood specimens. 

November 7, 2002 Approval Letter

Package Insert (PDF - 238 KB)

Summary of Safety and Effectiveness (PDF - 82 KB)


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: 07/27/2009
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