# Biofire Diagnostics, LLC

- Location (FDA's records): Salt Lake City, UT
- FDA decisions: 37 (2013–2026): 33 510(k) clearances and 4 De Novo grants
- Names in FDA's records: Biofire Diagnostics, LLC (29); Biofire Diagnostics, Inc. (5); Biofire Diagnostics (3)
- Product codes: QOF (7), PCH (6), PEN (6), OCC (5), PLO (2), QDS (2), QDP (2), PZF (1), QSN (1), NHT (1), NSU (1), OEH (1)
- 510(k) review time since 2016: median 90 days, against 147 for FDA's reviews in the same codes and years (7 of 11 faster)
- Predicates its devices cite: 34 (23 its own); citations of its devices by later devices: 64 (23 its own)
- Recalls linked to its devices: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Idaho Technology, Inc.: 8 (https://510kreport.com/company/idaho-technology)
- Luminex Molecular Diagnostics, Inc.: 1 (https://510kreport.com/company/luminex-molecular-diagnostics)
- Nanosphere, Inc.: 1 (https://510kreport.com/company/nanosphere)
- Curetis GmbH: 1 (https://510kreport.com/company/curetis)

## Firms that cite its devices most
- Hologic, Inc.: 8 (https://510kreport.com/company/hologic)
- QIAGEN GmbH: 4 (https://510kreport.com/company/qiagen)
- Diasorin Molecular, LLC: 3 (https://510kreport.com/company/diasorin-molecular)
- Nanosphere, Inc.: 3 (https://510kreport.com/company/nanosphere)
- Genmark Diagnostics, Incorporated: 3 (https://510kreport.com/company/genmark-diagnostics)
- Becton, Dickinson & CO: 3 (https://510kreport.com/company/becton-dickinson)
- Biofire Diagnostics, LLC (Biomerieux): 2 (https://510kreport.com/company/biofire-diagnostics-biomerieux)
- Roche Molecular Systems, Inc.: 2 (https://510kreport.com/company/roche-molecular-systems)

## Its most-cited devices
- DEN200031: BioFire Respiratory Panel 2.1 (RP2.1) (2021), cited by 13
- K140407: Filmarray Gastrointestinal (GI) Panel (2014), cited by 8
- K143005: FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (2015), cited by 4
- K160459: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (2016), cited by 4
- K123620: Filmarray Respiratory Panel (RP) (2013), cited by 4
- K130914: Filmarray Blood Culture Identification (Bcid) Panel (2013), cited by 4

## Recent decisions
- K262136: BIOFIRE SPOTFIRE Vaginitis (VG) Panel (Oct 21, 2026)
- K263054: BIOFIRE Respiratory Panel 2.1 (RP2.1) (Sep 22, 2026)
- K243544: BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (Aug 14, 2025)
- K243885: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (Jan 16, 2025)
- K243759: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) (Dec 20, 2024)
- K242367: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (Nov 7, 2024)
- K241194: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini (May 30, 2024)
- K232954: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel (Mar 26, 2024)

Source page: https://510kreport.com/company/biofire-diagnostics