Device Dossier

Clinical chemistry-specific protein IVDs

Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 3, sponsor Beckman Coulter). ARTG…

Intended purpose

IVDs that are paramagnetic particle, chemiluminescent immunoassays used for the qualitative and/or quantitative determination of proteins specific to clinical chemistry in human serum and plasma.

TGA Public Summary