BioFire Defense, LLC
Salt Lake City, UT, US
BioFire Defense, LLC appears in FDA device records in Salt Lake City, UT. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for BioFire Defense, LLC between 2017 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | PMN | Substantially Equivalent | |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | PRD | Substantially Equivalent | |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | QVR | Substantially Equivalent | |
| K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel | QMV | Substantially Equivalent | |
| K221460 | BioFire COVID-19 Test 2 | QQX | Substantially Equivalent | |
| K211079 | BioFire COVID-19 Test 2 | QQX | Substantially Equivalent | |
| K202382 | FilmArray Global Fever Panel External Control Kit | PMN | Substantially Equivalent | |
| DEN200043 | FilmArray Global Fever Panel | QMV | Unknown | |
| K170883 | FilmArray NGDS Warrior Panel | PRD | Substantially Equivalent | |
| DEN160048 | FilmArray NGDS Warrior Panel | PRD | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010770794 | 3010770794 | BioFire Defense, LLC | 79 W 4500 S Ste 14, Salt Lake City, UT 84107 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- OZZBordetella Pertussis Dna Assay System
- OZYChlamydophila Pneumoniae Dna Assay System
- QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
- OEMHuman Metapneumovirus (Hmpv) Rna Assay System
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
- NSUInstrumentation For Clinical Multiplex Test Systems
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- QVRMultiplex Nucleic Acid Detection System For Biothreat Agents
- OZXMycoplasma Pneumoniae Dna Assay System
- OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay
- OOUParainfluenza Multiplex Nucleic Acid Assay
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- POGReagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test
- OCCRespiratory Virus Panel Nucleic Acid Assay System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2877-2026 | FilmArray 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 FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA). | Firm 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. | Class II | Open, Classified | |
| Z-2609-2025 | FilmArray 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. | Class II | Open, Classified | |
| Z-1448-2020 | FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only | The 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. | Class III | Terminated | |
| Z-2644-2014 | JBAIDS 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 pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis. | 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. | Class III | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets BioFire Defense, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain