Device Dossier
Clinical chemistry hormone IVDs
Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Sigma Company). ARTG record, intended…
- GMDN category: CT850 - Clinical chemistry hormone IVDs
- Sponsor: Sigma Company
Intended purpose
This is a low sensitive urinary rapid test for the determination of the hCG (human Chorionic Gonadotropin) level in urine for home use, to determine the outcome after a previously confirmed Termination of intrauterine Pregnancy (ToP) of first trimester and miscarriage.