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Data / Medical devices / United States / BioFire Defense, LLC

BioFire Defense, LLC: FDA-registered device maker in Salt Lake City, UT, United States, 10 510(k) clearances

BioFire Defense, LLC is registered with the FDA (registration 3010770794) in Salt Lake City, UT, United States. It lists 17 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 12, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch BioFire Defense, LLC
FDA registration number
3010770794
Address
79 W 4500 S Ste 14, Salt Lake City, UT, United States, 84107
Owner or operator
BIOMERIEUX SA (8020790)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
February 18, 2015
Registered through
2026
Brand names listed
BIOFIRE FILMARRAY TF Panel, BIOFIRE FILMARRAY Tropical Fever (TF) Panel, BIOFIRE FILMARRAY Tropical Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel, BIOFIRE SPOTFIRE Control Station, BIOFIRE SPOTFIRE Module, BIOFIRE SPOTFIRE Respiratory (R) Panel and more

Devices it lists

DeviceProduct codeClassRoleSource
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysPMN2Manufactureraccessdata.fda.gov
Bordetella Pertussis Dna Assay SystemOZZ2Repackager or relabeleraccessdata.fda.gov
Chlamydophila Pneumoniae Dna Assay SystemOZY2Repackager or relabeleraccessdata.fda.gov
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile IllnessQMV2Contract manufacturer, Manufactureraccessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay SystemOEM2Repackager or relabeleraccessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid AssayOZE2Repackager or relabeleraccessdata.fda.gov
Instrumentation For Clinical Multiplex Test SystemsNSU2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsQOF2Repackager or relabeleraccessdata.fda.gov
Multiplex Nucleic Acid Detection System For Biothreat AgentsQVR2Manufactureraccessdata.fda.gov
Mycoplasma Pneumoniae Dna Assay SystemOZX2Repackager or relabeleraccessdata.fda.gov
Non-Sars Coronavirus Multiplex Nucleic Acid AssayOTG2Repackager or relabeleraccessdata.fda.gov
PRDPRDManufactureraccessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid AssayOOU2Repackager or relabeleraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNManufactureraccessdata.fda.gov
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic AcidPOGNManufactureraccessdata.fda.gov
Respiratory Specimen Nucleic Acid Sars-Cov-2 TestQQX2Manufactureraccessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay SystemOCC2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 12, 2025K243822BioFire Warrior Panel; BioFire Warrior Panel Control KitPRDSubstantially EquivalentBiofire Defense, LLCaccessdata.fda.gov
March 22, 2023K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelQVRSubstantially EquivalentBiofire Defense, LLCaccessdata.fda.gov
February 3, 2023K213954BIOFIRE SPOTFIRE Respiratory (R) PanelQOFSubstantially EquivalentBiofire Diagnosticsaccessdata.fda.gov
October 20, 2022K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelQMVSubstantially EquivalentBiofire Defense, LLCaccessdata.fda.gov
July 25, 2022K221460BioFire COVID-19 Test 2QQXSubstantially EquivalentBiofire Defense, LLCaccessdata.fda.gov
November 1, 2021K211079BioFire COVID-19 Test 2QQXSubstantially EquivalentBiofire Defense, LLCaccessdata.fda.gov
November 20, 2020K202382FilmArray Global Fever Panel External Control KitPMNSubstantially EquivalentBiofire Defense, LLCaccessdata.fda.gov
November 20, 2020DEN200043FilmArray Global Fever PanelQMVUnknownBiofire Defense, LLCaccessdata.fda.gov
June 22, 2017K170883FilmArray NGDS Warrior PanelPRDSubstantially EquivalentBiofire Defense, LLCaccessdata.fda.gov
January 30, 2015K143178FilmArray 2.0 SystemNSUSubstantially EquivalentBiofire Diagnostics, LLCaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 16, 202699459Class IIOngoingFilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArrFirm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.accessdata.fda.gov
July 10, 202597286Class IIOngoingFilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.accessdata.fda.gov
August 20, 201984887Class IIITerminatedFilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx OnlyThe firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.accessdata.fda.gov
August 13, 201469032Class IIITerminatedJBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.accessdata.fda.gov

Compare with other makers

Updated August 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.