Clinical chemistry hormone IVDs - ARTG 427685
Access comprehensive regulatory information for Clinical chemistry hormone IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 427685 and sponsored by Cole Supplies Pty Ltd, manufactured by Guangzhou Decheng Biotechnology Co Ltd in China. The device registration started on November 10, 2023.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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.