Atellica IM Hepatitis C (aHCV) - Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Siemens Healthcare Pty Ltd

Klasse:

Class 4

Fremstillet af:

Siemens Healthcare Diagnostics Inc 511 Benedict Avenue, Tarrytown, NY, 10591 United States Of America

Terapeutisk område:

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

Terapeutiske indikationer:

Atellica IM aHCV assay is an indirect 2-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 human serum and plasma (EDTA, lithium heparin, and sodium heparin). 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.

Autorisation status:

A

Autorisation dato:

2019-08-05