ARTG 314912Software IVDs
ARTG ID: 314912 · Biomerieux Australia Pty Ltd · BioFire Diagnostics LLC · Class I · Started February 28, 2019
Good Name: Biomerieux Australia Pty Ltd - Software IVDs
- Risk Class
- Class I
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 314912
- Start Date
- February 28, 2019
- Effective Date
- February 28, 2019
- Country
- United States of America
- Address
- 515 Colorow Dr, Salt Lake City, Utah, 84108
Software that is supplied separately to an IVD medical device (e.g. FilmArray) but which is intended to operate or influence the IVD.
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 registered under ARTG number 314912 and 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.