ARTG 395461Pharmacogenetic IVDs
ARTG ID: 395461 · Southern Cross Diagnostics Pty Ltd · Yourgene Health UK Limited · Class IIb · Started September 05, 2022
Good Name: Southern Cross Diagnostics Pty Ltd - Pharmacogenetic IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 395461
- Start Date
- September 05, 2022
- Effective Date
- September 05, 2022
- Country
- United Kingdom
- Address
- Skelton House Lloyd Street North Manchester Science Park, Manchester, M15 6SH
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).
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.
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