bioMerieux SA VIDAS HIV DUO Ultra - HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Biomerieux Australia Pty Ltd

Class:

Class 4

Manufactured by:

Biomerieux SA 376 Chemin de l'Orme, Marcy, L Etoile, 69280 France

Therapeutic area:

48445 - HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)

Therapeutic indications:

An automated HIV infection screening test for use on the VIDAS family instruments, for the combined detection of anti-HIV-1 (groups M and O) and anti-HIV-2 total immunoglobulins and HIV-1 p24 antigen in human serum or plasma (lithium heparin or EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). An automated HIV infection screening test for use on the VIDAS family instruments, for the combined detection of anti-HIV-1 (groups M and O) and anti-HIV-2 total immunoglobulins and HIV-1 p24 antigen in human serum or plasma (lithium heparin or EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay).

Authorization status:

A

Authorization date:

2015-01-29