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