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Infectious disease IVDs

Access comprehensive regulatory information for Infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Biomerieux Australia Pty Ltd, manufactured by BioFire Diagnostics LLC in United States of America. The device registration started on November 11, 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 I
Class I
Infectious disease IVDs
Australia TGA ARTG Registered Device
Good Name: Biomerieux Australia Pty Ltd - Infectious disease 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 infectious agents capable of causing disease, including viruses, bacteria, fungi, parasites and/or prions.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD-Export
Registration Information
Start Date
November 11, 2022
Effective Date
November 11, 2022
Manufacturer
Country
United States of America
Address
515 Colorow Dr, Salt Lake City, Utah, 84108