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
IVDs used as an aid in the screening of carriers for, and diagnosis of, inherited genetic disorders which includes but is not limited to sex-linked disorders and autosomal recessive/dominant disorders.