Device Category Dossier

CT903 - Inborn/inherited genetic disorder IVDs

Device Category Dossier for CT903 - Inborn/inherited genetic disorder IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

In vitro diagnostic devices detect genetic mutations and variants through molecular techniques such as polymerase chain reaction and hybridisation to identify inborn and inherited genetic disorders. These devices are used for screening and confirmation of inherited genetic conditions in newborns and other patient populations, including severe combined immunodeficiency and spinal muscular atrophy.