Device Category Dossier

CT287 - Clinical Chemistry IVDs

Device Category Dossier for CT287 - Clinical Chemistry IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Clinical chemistry in vitro diagnostic devices are used for the qualitative or quantitative determination of chemical, biological or immunological components including electrolytes, enzymes, substrates, specific proteins, hormones, products of metabolism, trace elements, and autoimmune markers. These devices are employed in clinical laboratory settings to assess biomarkers in blood plasma, often generating risk scores for conditions such as diabetic kidney disease in patients with type 2 diabetes, as well as for detecting pregnancy and other metabolic or immunological conditions.