Vaccines, Blood & Biologics

ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay

PMA: BP140103
Device Generic Name: Human Immunodeficiency Virus (HIV) p24 antigen and antibodies to HIV Type 1 (HIV-1 group M and group O) and/or Type 2
Tradename: ADVIA Centaur® HIV Ag/Ab Combo (CHIV) Assay
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Indications:

  • An in vitro diagnostic immunoassay for the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2, in serum using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur CHIV assay is intended to be used as an aid in the diagnosis of HIV infection in pediatric and adult populations, including pregnant women.

Approval Date: June 8, 2015

Page Last Updated: 03/07/2018
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