Device Dossier

ARCHITECT Anti-HBs Assay - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Device Dossier for ARCHITECT Anti-HBs Assay - Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay (Hepatitis B virus surface…

Intended purpose

A chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of antibody to Hepatitis B surface antigen (Anti-HBs) in clinical specimens.

Functional description

The ARCHITECT Anti-HBs assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of antibody to Hepatitis B surface antigen (anti-HBs) in clinical specimens.

TGA Public Summary