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  1. Approved Blood Products

Determine HIV-1/2 Ag/Ab Combo

PMA:  BP120037
Proper Name:  Determine HIV-1/2 Ag/Ab Combo
Tradename: None
Manufacturer: Abbott Diagnostics Scarborough, Inc.
Indications: 

  • The Determine HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Determine HIV-1/2 Ag/Ab Combo Assay only.
  • The Determine HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodefciency Virus Type 1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV Type 1 and Type 2 (HIV-1 and HIV-2) in human serum, plasma, capillary (fngerstick) whole blood or venipuncture (venous) whole blood.
  • The Determine HIV-1/2 Ag/Ab Combo 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.
  • The test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV test are available, this test can be used in appropriate multi-test algorithms.

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