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.

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