Device Category Dossier

Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Device Category Dossier for Hepatitis C virus total antibody IVD, kit, chemiluminescent assay. Australian ARTG records, sponsors, device class — compiled…

Hepatitis

C virus antibody immunoassays are chemiluminescent microparticle immunoassays used for qualitative detection of antibodies to hepatitis C virus in human specimens including serum, plasma, and dried blood spots. These assays are used for diagnostic purposes and screening of blood donations.