Device Dossier
Clinical chemistry hormone IVDs
Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor KD & A). ARTG record, intended purpose,…
- GMDN category: CT850 - Clinical chemistry hormone IVDs
Intended purpose
In vitro diagnostic tests for home use. Pregnancy tests intended for the detection of human Chorionic Gonadotrophin (hCG) in urine. Ovulation tests intended for the detection of an increase (surge) in Luteinising Hormone (LH), or in LH and estrogen in urine.