Company · US
Biofire Defense, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (1 in 12 months)
4recalls (1 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PRD | 6 | |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 2 |
| QMV | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness | 2 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 2 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 1 |
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 17, 2026 | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit Biofire Defense, LLC | PMN |
| Mar 12, 2025 | K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit Biofire Defense, LLC | PRD |
| Mar 22, 2023 | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Biofire Defense, LLC | QVR |
| Oct 20, 2022 | K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel Biofire Defense, LLC | QMV |
| Jul 25, 2022 | K221460 | BioFire COVID-19 Test 2 Biofire Defense, LLC | QQX |
| Nov 1, 2021 | K211079 | BioFire COVID-19 Test 2 Biofire Defense, LLC | QQX |
| Nov 20, 2020 | K202382 | FilmArray Global Fever Panel External Control Kit Biofire Defense, LLC | PMN |
| Nov 20, 2020 | DEN200043 | FilmArray Global Fever Panel Biofire Defense, LLC | QMV |
| Jun 22, 2017 | K170883 | FilmArray NGDS Warrior Panel Biofire Defense, LLC | PRD |
| Feb 14, 2017 | DEN160048 | FilmArray NGDS Warrior Panel Biofire Defense, LLC | PRD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2026 | Biofire Defense 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 Open, Classified |
PRD | K170883 |
| Sep 19, 2025 | Biofire Defense 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. Open, Classified |
PRD | K170883 |
| Feb 18, 2020 | Biofire Defense FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only Terminated |
PRD | K170883 |
| Sep 15, 2014 | Biofire Defense 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 Terminated |
NHT | K131930 |