ADVIA Centaur HCV (aHCV) - Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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:

48360 - Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Therapeutic indications:

ADVIA Centaur HCV is an indirect two wash sandwich immunoassay used for the detection of IgG antibody to hepatitis C virus (HCV) in human serum or plasma. An in vitro diagnostic immunoassay for the qualitative determination of IgG antibodies to hepatitis C virus (HCV) in clinical specimens. This IVD may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection.

Authorization status:

A

Authorization date:

2015-05-27