Device Dossier
Clinical chemistry hormone IVDs
Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Polished Brands). ARTG record, intended…
- GMDN category: CT850 - Clinical chemistry hormone IVDs
Intended purpose
An IVD intended to be used for the rapid qualitative determination of human chorionic gonadotropin (HCG) in human urine samples as an aid in the early detection of pregnancy and an IVD intended to be used for the rapid qualitative determination of luteinizing hormone (LH) in human urine samples as an aid in the prediction of ovulation.