Instrument/analyser IVDs
Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Emergence Technology Pty Ltd, manufactured by Ustar Biotechnologies (Hangzhou) Ltd in China. The device registration started on November 02, 2020.
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.
This product is a semi-automated nucleic acid amplification and detection analyser - it is based on a three-stage magnetically permeable extraction technology and the principle of fluorescence polymerase chain reaction, and is used together with a matching detection kit for qualitative detection of pathogen nucleic acid sequences from a clinical specimen.