Device Dossier
Inborn/inherited genetic disorder IVDs
Device Dossier for Inborn/inherited genetic disorder IVDs (CT903 - Inborn/inherited genetic disorder IVDs, Class 3, sponsor Abacus dx). ARTG record,…
- GMDN category: CT903 - Inborn/inherited genetic disorder IVDs
Intended purpose
In vitro diagnostic kits intended for the screening of inherited genetic disorders including for severe combined immunodeficiency (SCID) and Spinal Muscular Atrophy (SMA) in newborns.