BioFire Diagnostics, LLC - Product Owner 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.
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11 Devices
3 Device Classes
BioFire Diagnostics, LLC
Product Owner
11
Total Devices
3
Device Classes
2015
Earliest
2023
Latest
Recent Registrations
Latest 10 HSA device registrations
BioFire Diagnostics BioFire Joint Infection Panel
DE0508701
CLASS C
Nov 29, 2023
BioFire Diagnostics Respiratory Panel 2.1 plus (RP2.1plus)
DE0507624
CLASS D IVD
Dec 22, 2022
BioFire Diagnostics Respiratory Panel 2.1 (RP2.1)
DE0507420
CLASS D IVD
Oct 28, 2022
BioFire Diagnostics FilmArray Blood Culture Identification 2 (BCID2) Panel
DE0506525
CLASS C IVD
Dec 27, 2021
BioFire Diagnostics FilmArrayยฎ Pneumonia Panel & Pneumonia Panel Plus
DE0504227
CLASS C IVD
Mar 13, 2020
BioFire Diagnostics FilmArray RP2/RP2 Plus
DE0502362
CLASS C IVD
Nov 21, 2018
BioFire Diagnostics FilmArray Instruments
DE0501954
CLASS C IVD
Jul 27, 2018
BioFire Diagnostics FilmArray Meningitis/Encephalitis (ME) Panel
DE0018960
CLASS C IVD
Feb 14, 2017
BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel
DE0018501
CLASS C IVD
Aug 25, 2016
BioFire Diagnostics FilmArray Respiratory Panel Kit
DE0016973
CLASS C IVD
Mar 30, 2015
Device Class Distribution
Devices by class
CLASS C
1
9.1% of total
CLASS C IVD
8
72.7% of total
CLASS D IVD
2
18.2% of total

