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Multiple clinical chemistry constituent IVDs

Australia TGA ARTG Registered Device · Roche Diagnostics Australia Pty Limited · Techno-path Manufacturing Ltd · Class IIb · Started January 17, 2022

Good Name: Roche Diagnostics Australia Pty Limited - Multiple clinical chemistry constituent IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
Start Date
January 17, 2022
Effective Date
January 17, 2022
Sponsor
Manufacturer
Country
Ireland
Address
Fort Henry Business Park Ballina, Co Tipperary
Intended purpose

Quality Control serums intended to monitor the precision of laboratory testing procedures for multiple analytes.

About this record

Access comprehensive regulatory information for Multiple clinical chemistry constituent IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Techno-path Manufacturing Ltd in Ireland. The device registration started on January 17, 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.

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