Atellica IM Anti-Hepatitis B core Total - Hepatitis B virus core total 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:

48304 - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Terapeutiske indikationer:

The Atellica IM HBcT assay is a 2-wash antigen sandwich immunoassay in which antigens are bridged by antibody present in the patient sample. An in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus in human serum and EDTA plasma. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV-infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

Autorisation status:

A

Autorisation dato:

2020-01-09