Device Dossier

Interpretive software IVDs

Device Dossier for Interpretive software IVDs (CT910 - Interpretive software IVDs, Class 3, sponsor Thermo Fisher Scientific). ARTG record, intended…

Intended purpose

B·R·A·H·M·S Fast Screen pre I plus software for non-invasive risk assessment of fetal trisomy 21, 18 and 13 in the 1st, of trisomy 21, 18 and fetal neural tube defect in the 2nd trimester of pregnancy as well as for 1st trimester risk assessment for developing pre-eclampsia

TGA Public Summary