Australia TGA ARTG record

Multiple infectious organism IVDs

Australia TGA ARTG Registered Device · Biomerieux Australia Pty Ltd · BioFire Diagnostics LLC · Class IIb · Started June 05, 2014

Good Name: Biomerieux Australia Pty Ltd - Multiple infectious organism IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: June 05, 2014
Effective Date: January 18, 2023

Sponsor

Name: Biomerieux Australia Pty Ltd

Manufacturer

Name: BioFire Diagnostics LLC
Country: United States of America
Address: 515 Colorow Dr, Salt Lake City, Utah, 84108

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

About this record

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.