Genscreen ULTRA HIV Ag-Ab - HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
Bio-Rad Laboratories Pty Ltd
Class:
Class 4
Manufactured by:
Bio-Rad 3 Boulevard Raymond Poincare, 92430 MARNES-LA-COQUETTE France
Therapeutic area:
48445 - HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
Therapeutic indications:
A qualitative enzyme immunoassay kit for the detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma. The Genscreen? ULTRA HIV Ag-Ab is a qualitative enzyme immunoassay kit for the detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma. This kit can be used for both HIV Ag and HIV Ab screening
Authorization status:
A
Authorization date:
2014-03-01
