Multiple-bacteria IVDs - ARTG 473711
Access comprehensive regulatory information for Multiple-bacteria IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 473711 and sponsored by Pure Sponsor Pty Ltd, manufactured by Guangzhou Hybribio Medicine Technology Ltd in China. The device registration started on December 18, 2024.
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.
Hybribio STD3 Real-time PCR Kit is designed for in-vitro qualitative detection of 3 sexually transmitted pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, and Ureaplasma urealyticum in male urethral secretions and female cervical exfoliated cells. It is used as an aid in diagnosis of Chlamydia, Gonorrhea and Ureaplasma in symptomatic (e.g. gonorrhoea and non-gonococcal urethritis, cervicitis, etc) individuals