Product owner profile
BioFire Diagnostics, LLC
Profile overview
- Total Devices
- 11
- Device Classes
- 3
- Earliest
- 2015
- Latest
- 2023
Recent registrations
Latest 10 HSA device registrations
BioFire Diagnostics BioFire Joint Infection PanelNov 29, 2023
Registration: DE0508701
Class: CLASS C
BioFire Diagnostics Respiratory Panel 2.1 plus (RP2.1plus)Dec 22, 2022
Registration: DE0507624
Class: CLASS D IVD
BioFire Diagnostics Respiratory Panel 2.1 (RP2.1)Oct 28, 2022
Registration: DE0507420
Class: CLASS D IVD
BioFire Diagnostics FilmArray Blood Culture Identification 2 (BCID2) PanelDec 27, 2021
Registration: DE0506525
Class: CLASS C IVD
BioFire Diagnostics FilmArray® Pneumonia Panel & Pneumonia Panel PlusMar 13, 2020
Registration: DE0504227
Class: CLASS C IVD
BioFire Diagnostics FilmArray RP2/RP2 PlusNov 21, 2018
Registration: DE0502362
Class: CLASS C IVD
BioFire Diagnostics FilmArray InstrumentsJul 27, 2018
Registration: DE0501954
Class: CLASS C IVD
BioFire Diagnostics FilmArray Meningitis/Encephalitis (ME) PanelFeb 14, 2017
Registration: DE0018960
Class: CLASS C IVD
BioFire Diagnostics FilmArray Gastrointestinal (GI) PanelAug 25, 2016
Registration: DE0018501
Class: CLASS C IVD
BioFire Diagnostics FilmArray Respiratory Panel KitMar 30, 2015
Registration: DE0016973
Class: CLASS C IVD
Device class distribution
Devices by class
- CLASS C
- 1 (9.1%)
- CLASS C IVD
- 8 (72.7%)
- CLASS D IVD
- 2 (18.2%)
About this profile
Explore comprehensive product owner profile for BioFire Diagnostics, LLC through Pure Global AI's free Singapore medical device database. This company owns 11 medical devices registered with HSA across 3 device classes. Their registration history spans from Mar 30, 2015 to Nov 29, 2023.
This page provides detailed insights including recent registrations, device class distribution (CLASS C IVD: 8, CLASS D IVD: 2, CLASS C: 1), and complete regulatory information from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry.
Free Owner ProfilePowered by Pure Global AI11 Devices3 Device Classes