Alinity s HBsAg Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Abbott Australasia Pty Ltd Diagnostic Division

Classe:

Class 4

Fabricado por:

Abbott Ireland Diagnostics Division Finisklin Business Park, SLIGO Ireland

Área terapêutica:

48321 - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Indicações terapêuticas:

This assay is a one-step immunoassay for the qualitative detection of HBsAg in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. The Alinity s HBsAg assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected up to 24 hours postmortem (non-heart-beating), on the Alinity s System.

Status de autorização:

A

Data de autorização:

2018-11-20