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Multiple infectious organism IVDs

Access comprehensive regulatory information for Multiple infectious organism 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 BioFire Diagnostics LLC in United States of America. The device registration started on June 05, 2014.

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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Class IIb
Class IIb
Multiple infectious organism IVDs
Australia TGA ARTG Registered Device
Good Name: Biomerieux Australia Pty Ltd - Multiple infectious organism IVDs
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Intended Purpose

IVDs intended to be used in testing to provide information about mixed infection with or exposure to multiple specified infectious organisms from different microbial groups, which may include viruses, bacteria, fungi, parasites and/or prions

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
June 05, 2014
Effective Date
January 18, 2023
Manufacturer
Country
United States of America
Address
515 Colorow Dr, Salt Lake City, Utah, 84108