Australia TGA ARTG record

Infectious disease IVDs

Australia TGA ARTG Registered Device · Biomerieux Australia Pty Ltd · BioFire Diagnostics LLC · Class I · Started November 11, 2022

Good Name: Biomerieux Australia Pty Ltd - Infectious disease IVDs

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

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 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.

About this record

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.