Device Dossier
ARCHITECT HBsAg Qualitative II assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Device Dossier for ARCHITECT HBsAg Qualitative II assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay (Hepatitis B virus…
Intended purpose
The ARCHITECT HBsAg Qualitative II assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma including specimens collected up to 24 hours post-mortem (non-heart-beating).
Functional description
A chemiluminescent microparticle(CMIA)assay for the qualitative detection of hepatitis B surface antigen in human clinical specimens.