Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002773840

FEI Number

3002773840

Entity Name

BioFire Diagnostics, LLC

City/State/Country

Salt Lake City, UT, US

Establishment Address

515 Colorow Drive, Salt Lake City, UT 84108, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

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

K243463

PMA Number

N/A

All Registered Proprietary Names

BioFire Respiratory Panel 2.1 BioFire RP2.1 FilmArray 2 FilmArray® Gastrointestinal (GI) Panel BIOFIRE FILMARRAY BCID2 Panel BIOFIRE BCID2 Panel BIOFIRE Blood Culture Identification 2 Panel FilmArray Respiratory Panel (RP) For Use With FilmArray Torch FilmArray ME Panel for use on FilmArray Torch BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini BIOFIRE SPOTFIRE R/ST Panel Mini BioFire BCID2 Panel BioFire Blood Culture Identification 2 Panel BioFire Blood Culture Identification 2 (BCID2) Panel FILMARRAY GI Panel BIOFIRE GI Panel BIOFIRE FILMARRAY GI Panel BIOFIRE FILMARRAY Gastrointestinal Panel BIOFIRE FILMARRAY Gastrointestinal (GI) Panel FilmArray Gastrointestinal (GI) Panel BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel BIOFIRE SPOTFIRE R/ST Panel FilmArray GI Panel for use with FilmArray Torch BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid BIOFIRE FILMARRAY GI Panel Mid BIOFIRE SPOTFIRE Module BIOFIRE SPOTFIRE Respiratory (R) Panel BIOFIRE SPOTFIRE Control Station BioFire Pneumo plus Panel BioFire Pneumonia Plus Panel BioFire FilmArray Pneumonia plus Panel BIOFIRE SPOTFIRE R Panel Mini BIOFIRE SPOTFIRE Respiratory (R) Panel Mini BIOFIRE FILMARRAY Pneumonia Panel plus BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini SPOTFIRE R/ST Panel Mini BIOFIRE FILMARRAY Gastroinestinal (GI) Panel BIOFIRE GI Panel BioFire Pneumonia Panel BioFire Pneumo Panel BioFire FilmArray Pneumonia Panel BIOFIRE FILMARRAY Tropical Fever Panel BIOFIRE FILMARRAY TF Panel BIOFIRE FILMARRAY Tropical Fever (TF) Panel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2021-03-18
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2015-02-18
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2015-02-25
PEO	Fungal Organisms, Nucleic Acid-Based Assay	Microbiology	Class 2	866.3365	2025-01-08
PEN	Gram-Negative Bacteria And Associated Resistance Markers	Microbiology	Class 2	866.3365	2025-01-08
PAM	Gram-Positive Bacteria And Their Resistance Markers	Microbiology	Class 2	866.3365	2025-01-08
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-03-07
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2016-03-07
OZX	Mycoplasma Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2016-03-07
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2016-03-07
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-03-07
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	Class 2	866.3980	2016-03-07
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2016-03-07
PLO	Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System	Microbiology	Class 2	866.3970	2016-03-21
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2025-09-05
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2025-09-05
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-09-05
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	Class 2	866.2680	2025-09-05
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2025-09-05
PEN	Gram-Negative Bacteria And Associated Resistance Markers	Microbiology	Class 2	866.3365	2020-03-24
PAM	Gram-Positive Bacteria And Their Resistance Markers	Microbiology	Class 2	866.3365	2020-03-24
PEO	Fungal Organisms, Nucleic Acid-Based Assay	Microbiology	Class 2	866.3365	2020-03-24
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2024-12-20
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2014-10-24
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2024-03-27
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2016-04-01
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2025-01-30
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
QDS	Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System	Pathology	Class 2	866.4001	2018-11-19
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2023-05-08
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2023-05-08
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2023-05-08
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2023-05-08
QDS	Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System	Pathology	Class 2	866.4001	2023-03-28
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2024-06-05
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2024-06-05
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2024-06-05
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2024-06-05
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	Class 2	866.2680	2024-06-05
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2023-03-28
QDP	Respiratory Panel	Microbiology	Class 2	866.3985	2018-11-14
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness	Microbiology	Class 2	866.3966	2024-12-20

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-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447

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3014515702	Nuclein, LLC	Austin, TX, US
3005248192	ABBOTT MOLECULAR, INC.	Des Plaines, IL, US
3009613136	CEPHEID AB	SOLNA Stockholm, SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002773840. Last updated year: 2026. Please use registration number 3002773840 when referencing this establishment in official correspondence.