Device Dossier

Clinical chemistry-specific protein IVDs

Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor PM Separations). ARTG…

Intended purpose

CDT is the most specific parameter for chronic alcohol abuse. The Recipe analytical method ensures a reliable separation of the transferrin-isoforms asialo- to hexasialotransferrin. It allows for quantification of all transferrin isoforms, safe identification of genetic variants an screening for CDG syndromes.

TGA Public Summary