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BioFire Diagnostics LLC

Manufacturer • United States of America · 8 devices on the TGA ARTG · 2 device classes · Jun 04, 2014 – Nov 11, 2022

8
Total Devices
2
Device Classes
2014
Earliest
2022
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
Infectious disease IVDs
ARTG 399210
Class INov 11, 2022
Sponsor: Biomerieux Australia Pty Ltd
Infectious disease IVDs
Class INov 11, 2022
Sponsor: Biomerieux Australia Pty Ltd
Software IVDs
ARTG 314912
Class IFeb 28, 2019
Sponsor: Biomerieux Australia Pty Ltd
Software IVDs
Class IFeb 28, 2019
Sponsor: Biomerieux Australia Pty Ltd
Multiple infectious organism IVDs
Class IIbJun 05, 2014
Sponsor: Biomerieux Australia Pty Ltd
Multiple infectious organism IVDs
ARTG 224167
Class IIbJun 05, 2014
Sponsor: Biomerieux Australia Pty Ltd
Instrument/analyser IVDs
Class IJun 04, 2014
Sponsor: Biomerieux Australia Pty Ltd
Instrument/analyser IVDs
ARTG 224128
Class IJun 04, 2014
Sponsor: Biomerieux Australia Pty Ltd
Risk class distribution
Devices by risk class
Class I
6
75.0% of total
Class IIb
2
25.0% of total
About this profile

Explore comprehensive manufacturer profile for BioFire Diagnostics LLC through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 8 medical devices registered with TGA ARTG across 2 device classes. This manufacturer is based in United States of America. Their registration history spans from Jun 04, 2014 to Nov 11, 2022.

This page provides detailed insights including recent device registrations, risk class distribution (Class I: 6, Class IIb: 2), and complete regulatory information 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.

Free Manufacturer ProfilePowered by Pure Global AI8 Devices2 Device Classes