ADVIA Centaur HBc Total 2 (HBcT2) assay - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Siemens Healthcare Pty Ltd

Classe:

Class 4

Fabricado por:

Siemens Healthcare Diagnostics Products Ltd Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL United Kingdom

Área terapêutica:

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

Indicações terapêuticas:

The ADVIA Centaur HBcT2 assay is an antigen-bridging microparticle chemiluminescent immunoassay used for the detection of antibodies to hepatitis B core antigen in human serum or plasma. In vitro diagnostic use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human serum or plasma. This assay can be used as an aid in the diagnosis of individuals (neonates, children, adolescents, and adults) 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.

Status de autorização:

A

Data de autorização:

2023-05-31