Device Dossier

Clinical chemistry hormone IVDs

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

Intended purpose

The hCG Early Result Pregnancy Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. It is intended use for self-testing.

TGA Public Summary