Device Category Dossier

CT869 - Clinical chemistry autoimmune IVDs

Device Category Dossier for CT869 - Clinical chemistry autoimmune IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Enzyme-linked immunosorbent assays (ELISA) are in vitro diagnostic devices that detect and quantify antibodies to autoimmune marker compounds in human serum or plasma. These devices are used for the quantitative measurement of autoimmune biomarkers in clinical specimens.