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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Alere Determine HIV-1/2 Ag/Ab Combo

PMA:  BP120037
Proper Name:  Alere Determine HIV-1/2 Ag/Ab Combo
Tradename: None
Manufacturer: Alere Scarborough, Inc.
Indications: Alere Determine HIV–1/2 Ag/Ab Combo is an in vitro, visually read, rapid qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen and antibodies to both HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood. It is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2, including an acute HIV-1 infection, and may distinguish acute HIV-1 infection from established HIV-1 infection when the specimen is positive for HIV-1 p24 antigen and negative for anti-HIV-1 and anti-HIV-2 antibodies.

Approval Date: August 9, 2013