Device Dossier

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

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

Intended purpose

The Alinity i Anti-HBs assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of antibody to Hepatitis B surface antigen (anti-HBs) in human serum and plasma on the Alinity i analyzer.

Functional description

This assay is a two-step immunoassay for the quantitative determination of anti-HBs in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.

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