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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

Proper Name: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
Tradename: None
Manufacturer: OraSure Technologies
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

 

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