Device Dossier
Acquired genetic alteration IVDs
Device Dossier for Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Eurobio Scientific). ARTG record,…
- GMDN category: CT929 - Acquired genetic alteration IVDs
Intended purpose
An in vitro diagnostic kit for patients with estrogen-receptor-positive, HER-2 negative primary breast cancer to determine the risk of distant recurrence and to estimate the adjuvant chemotherapy benefit.