Hepatitis B virus IVDs

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Cepheid Holdings Pty Ltd

Classe:

Class 3

Fabricado por:

Cepheid AB Rontgenvagen 5, Solna, SE-171 54 Sweden

Área terapêutica:

CT704 - Hepatitis B virus IVDs

Indicações terapêuticas:

The Cepheid Xpert? HBV Viral Load (VL) assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals using the automated GeneXpert? Systems. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels.The test is not intended to be used as a donor screening test for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.

Status de autorização:

A

Data de autorização:

2019-10-17