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,…

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.

TGA Public Summary