Device Dossier

Clinical chemistry hormone IVDs

Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Emergo). ARTG record, intended purpose,…

Intended purpose

The One Step HCG Urine Test is a rapid pregnancy test. It detects the presence of human chorionic gonadotropin (“HCG”), which appears in urine very early during pregnancy. The One Step Ovulation Urine Test is a qualitative test used to predict when there is a LH surge, and in turn, when you are likely to ovulate. For in vitro self-testing use only. For external use only.

TGA Public Summary