Device Dossier

Clinical chemistry hormone IVDs

Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor PM Separations). ARTG record, intended…

Intended purpose

The ClinRep/ClinMass Complete kits (including control and calibrator material) allow for a quick and safe quantification neurotransmitters and hormones including metanephrines, catecholamines and steroids in clinical specimens. To be used by professionals in a laboratory environment.

TGA Public Summary