Device Dossier

Constitutional chromosomal disorder IVDs

Device Dossier for Constitutional chromosomal disorder IVDs (CT826 - Constitutional chromosomal disorder IVDs, Class 3, sponsor Southern Cross…

Intended purpose

Next generation DNA sequencing (NGS) in-vitro diagnostics intended to be used for human genetic testing including fetal aneuploidies and/or other prenatal and postnatal genetic anomalies.

TGA Public Summary