Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010770794

FEI Number

3010770794

Entity Name

BioFire Defense, LLC

City/State/Country

Salt Lake City, UT, US

Establishment Address

79 W 4500 S Ste 14, Salt Lake City, UT 84107, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOMERIEUX SA (Owner Number: 8020790)

Owner / Operator Contact Address

Chemin De L Orme, Marcy L Etoile, FR-69 69280, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220870

PMA Number

N/A

All Registered Proprietary Names

BioFire COVID-19 Test SARS-COV-2 R-GENE BioFire Warrior Panel Control Kit BioFire Warrior Panel BIOFIRE FILMARRAY Tropical Fever Panel BIOFIRE FILMARRAY TF Panel BIOFIRE FILMARRAY Tropical Fever (TF) Panel BioFire COVID-19 Test 2 BioFire Global Fever Panel BioFire COVID-19 Test 2 BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel FilmArray BioThreat-E Test BIOFIRE SPOTFIRE Module BIOFIRE SPOTFIRE Respiratory (R) Panel BIOFIRE SPOTFIRE Control Station BioFire Global Fever Special Pathogens Panel BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel BioFire Global Fever Panel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-31
PRD	N/A	N/A	Class N/A	N/A	2025-03-26
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2025-03-26
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness	Microbiology	Class 2	866.3966	2024-12-20
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2022-11-07
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness	Microbiology	Class 2	866.3966	2021-07-08
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2022-03-29
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2021-07-08
POG	Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid	Unknown	Class N	N/A	2020-05-11
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2023-02-13
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2023-02-13
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2023-02-13
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	Class 2	866.3980	2023-02-13
OZX	Mycoplasma Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2023-02-13
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2023-02-13
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2023-02-13
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2023-02-13
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2023-02-13
OZY	Chlamydophila Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2023-02-13
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2023-06-12
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness	Microbiology	Class 2	866.3966	2023-06-12
QVR	Multiplex Nucleic Acid Detection System For Biothreat Agents	Immunology	Class 2	866.4000	2023-06-12
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness	Microbiology	Class 2	866.3966	2022-11-07
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2022-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOMERIEUX SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1450405	BIOMERIEUX, INC.	LOMBARD, IL, US
3023036790	Specific Diagnostics	San Jose, CA, US
3025775667	BIOMERIEUX, INC.	Salt Lake City, UT, US
3008249922	BIOMERIEUX SA - Grenoble	Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR
3009307598	BIOMERIEUX SPAIN	Tres Cantos Madrid (Province), ES

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010770794. Last updated year: 2026. Please use registration number 3010770794 when referencing this establishment in official correspondence.