Vaccines, Blood & Biologics

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
(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: 08/17/2010
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