ADVIA Centaur HIV Ag/Ab Combo (CHIV) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
11-11-2017
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Available from:
Siemens Healthcare Pty Ltd
Class:
Class 4
Manufactured by:
Siemens Healthcare Diagnostics Inc 511 Benedict Avenue, Tarrytown, NY, 10591 United States Of America
Therapeutic area:
48446 - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Therapeutic indications:
The ADVIA Centaur CHIV assay is a two-wash antigen/antibody sandwich immunoassay using direct chemiluminometric technology An in vitro diagnostic immunoassay intended to be used in testing clinical specimens for the detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to human immunodeficiency virus type 1 (HIV-1), including group "O", and/or type 2 (HIV-2), to aid in the diagnosis of HIV infection.
Authorization status:
A
Authorization date:
2013-01-21
