Device Dossier

Interpretive software IVDs

Device Dossier for Interpretive software IVDs (CT910 - Interpretive software IVDs, Class 3, sponsor ACRA Regulatory Services). ARTG record, intended…

Intended purpose

Interpretative software intended to be used in antenatal screening for Down’s syndrome, trisomy 18, trisomy 13, pre-eclampsia and open neural tube defects. Suitable for first trimester, second trimester, Integrated and reflex DNA screening.

TGA Public Summary