Genscreen HIV-1 Antigen Assay - HIV1 antigen 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:
48458 - HIV1 antigen IVD, kit, enzyme immunoassay (EIA)
Therapeutic indications:
The Genscreen? HIV-1 Antigen Assay is intended to be used as a screen for donated blood and plasma and as an aid in the diagnosis and prognosis of HIV-1 infection. The Genscreen? HIV-1 Antigen Assay is intended to be used as an aid in the diagnosis and prognosis of HIV-1 infection.
Authorization status:
A
Authorization date:
2014-02-12
