Device Dossier
Clinical chemistry hormone IVDs
Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor CC Supplies). ARTG record, intended…
- GMDN category: CT850 - Clinical chemistry hormone IVDs
Intended purpose
Intended purpose - Digital Pregnancy Rapid test This test device is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This device is a self-testing IVD medical device for home use by lay person. Intended purpose - Digital Ovulation Rapid Test This test device is used for in vitro qualitative detection of Luteinizing Hormone (LH) level in human urine. It is suitable for the prediction of ovulation. It is a self-testing IVD medical device for home use by lay person.