Australia TGA ARTG record

Software IVDs

Australia TGA ARTG Registered Device · Biomerieux Australia Pty Ltd · BioFire Diagnostics LLC · Class I · Started February 28, 2019

Good Name: Biomerieux Australia Pty Ltd - Software IVDs

Device classification

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

Registration information

Start Date: February 28, 2019
Effective Date: February 28, 2019

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

Software that is supplied separately to an IVD medical device (e.g. FilmArray) but which is intended to operate or influence the IVD.

About this record

Access comprehensive regulatory information for Software 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 February 28, 2019.

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.