Pharmacogenetic IVDs - ARTG 395461
Access comprehensive regulatory information for Pharmacogenetic IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 395461 and sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Yourgene Health UK Limited in United Kingdom. The device registration started on September 05, 2022.
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.
For the simultaneous in vitro qualitative detection of DPYD gene mutations associated with increased risk of severe or fatal toxicity in response to treatment with 5-fluorouracil (5-FU).