Device Dossier

Constitutional chromosomal disorder IVDs

Device Dossier for Constitutional chromosomal disorder IVDs (CT826 - Constitutional chromosomal disorder IVDs, Class 3, sponsor Sysmex). ARTG record,…

Intended purpose

IVDs that are intended to be used in genetic testing for detecting, quantifying, diagnosing, monitoring or predicting the presence of chromosomal abnormalities of a constitutional nature (i.e. present in all cells of the body).

TGA Public Summary