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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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
(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