Device Dossier
Alinity s HBsAg Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Device Dossier for Alinity s HBsAg Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay (Hepatitis B virus surface antigen…
Intended purpose
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.
Functional description
This assay is an automated one-step immunoassay for the qualitative detection of HBsAg in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.