Australia TGA ARTG record

Pharmacogenetic IVDs

Australia TGA ARTG Registered Device · Southern Cross Diagnostics Pty Ltd · Yourgene Health UK Limited · Class IIb · Started September 05, 2022

Good Name: Southern Cross Diagnostics Pty Ltd - Pharmacogenetic IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: September 05, 2022
Effective Date: September 05, 2022

Sponsor

Name: Southern Cross Diagnostics Pty Ltd

Manufacturer

Name: Yourgene Health UK Limited
Country: United Kingdom
Address: Skelton House Lloyd Street North Manchester Science Park, Manchester, M15 6SH

Intended purpose

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).

About this record

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 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.