Device Dossier

Acquired genetic alteration IVDs

Device Dossier for Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor BGI Health (AU) Company). ARTG record,…

Intended purpose

A noninvasive in vitro diagnostic assay for qualitative detection of SDC2, ADHFE1 and PPP2R5C genes methylation isolated from human stool specimens.

TGA Public Summary