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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Abbott ARCHITECT HIV Ag/Ab Combo

Applicant: Abbott Laboratories
Product: ARCHITECT HIV Ag/Ab Combo 
PMA number:  BP090080/0
Indication for Use: As an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection
Approval Date: 6/18/2010

 

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