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Mycobacteria IVDs

Access comprehensive regulatory information for Mycobacteria IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Biomerieux Australia Pty Ltd, manufactured by Biomerieux SA in France. The device registration started on June 27, 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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TGA ARTG Official Data
Class IIb
Class IIb
Mycobacteria IVDs
Australia TGA ARTG Registered Device
Good Name: Biomerieux Australia Pty Ltd - Mycobacteria IVDs
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Intended Purpose

IVDs that are intended to be used in testing to provide information about infection with or exposure to Mycobacterium tuberculosis (Mtb).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
June 27, 2022
Effective Date
June 27, 2022
Manufacturer
Country
France
Address
376 Chemin de l'Orme, Marcy, L Etoile, 69280