Device Dossier

Elecsys HBsAg II (cobas e411/601/602) - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Device Dossier for Elecsys HBsAg II (cobas e411/601/602) - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay (Hepatitis B virus…

Intended purpose

Immunoassay for the in vitro qualitative determination of hepatitis B surface antigen (HBsAg) in human serum and plasma, for diagnostic use, screening of blood donations.

Functional description

An electrochemiluminescence immunoassay "ECLIA" intended for use on the cobas e immunoassay analyzers.

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