This page includes the latest FDA filings for Biofire Defense L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010770794 |
| FEI Number | 3010770794 |
| Name | BioFire Defense, LLC |
| Owner & Operator | BIOMERIEUX SA |
| Contact Address | CHEMIN DE L'ORME -- MARCY L'ETOILE FR-NOTA 69280 FR |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 79 W 4500 S Ste 14 Salt Lake City, UT 84107 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| BIOFIRE DEFENSE, LLC | FILMARRAY NGDS WARRIOR PANEL - CA DFA2-ASY-0012 | 2024-06-28 |
| BIOFIRE DEFENSE, LLC | FILMARRAY® COMMERCIAL LAPTOP COMP-SUB-0034 | 2024-03-27 |
| BIOFIRE DEFENSE, LLC | BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane DFA2-ASY-0019 | 2023-09-08 |
| BIOFIRE DEFENSE, LLC | BioFire® Global Fever Special Pathogens Panel DFA2-ASY-0018 | 2023-09-08 |
| BIOFIRE DEFENSE, LLC | BioFire® COVID-19 Test 2 DFA2-ASY-0016 | 2023-02-24 |
| BIOFIRE DEFENSE, LLC | BioFire® COVID-19 Test 2 DFA2-ASY-0015 | 2023-02-24 |
BioFire Defense, LLC | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit For The BioFire Global Fever Panel | 2022-10-20 |
BioFire Defense, LLC | BioFire COVID-19 Test 2 | 2021-11-01 |
| BIOFIRE DEFENSE, LLC | BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel DFA2-ASY-0006 | 2021-07-26 |
| BIOFIRE DEFENSE, LLC | BioFire® Global Fever Panel DFA2-ASY-0004 | 2021-07-26 |
BioFire Defense, LLC | FilmArray Global Fever Panel External Control Kit | 2020-11-20 |
BioFire Defense, LLC | FilmArray Global Fever Panel | 2020-11-20 |
BioFire Defense, LLC [BIOMERIEUX SA] | BioFire COVID-19 Test | 2020-03-31 |
| BIOFIRE DEFENSE, LLC | JBAIDS JRPD-ASY-0136 | 2020-02-12 |
| BIOFIRE DEFENSE, LLC | JBAIDS JRPD-ASY-0138 | 2020-02-12 |
| BIOFIRE DEFENSE, LLC | JBAIDS JRPD-ASY-0137 | 2020-02-12 |
| BIOFIRE DEFENSE, LLC | FilmArray® NGDS Warrior Panel NGDS-ASY-0007 | 2019-08-02 |
| BIOFIRE DEFENSE, LLC | NGDS NGDS-ASY-0006 | 2019-08-02 |
| BIOFIRE DEFENSE, LLC | FilmArray® 2.0 Instrument NGDS Configuration NGDS-ASY-0004 | 2018-07-06 |
| BIOFIRE DEFENSE, LLC | FilmArray® 2.0 Instrument NGDS Configuration NGDS-ASY-0002U | 2018-07-06 |
| BIOFIRE DEFENSE, LLC | FILMARRAY FLM1-ASY-0121 | 2018-07-06 |
| BIOFIRE DEFENSE, LLC | FilmArray® 2.0 Instrument NGDS Configuration NGDS-ASY-0002 | 2018-07-06 |
| BIOFIRE DEFENSE, LLC | JBAIDS JRPD-ASY-0123 | 2018-07-06 |
| BIOFIRE DEFENSE, LLC | JBAIDS JRPD-ASY-0116 | 2018-07-06 |
| BIOFIRE DEFENSE, LLC | JBAIDS JRPD-ASY-0124 | 2018-07-06 |
| BIOFIRE DEFENSE, LLC | JBAIDS JRPD-ASY-0016 | 2018-07-06 |
| BIOFIRE DEFENSE, LLC | JBAIDS JRPD-ASY-0001 | 2018-07-06 |
BioFire Defense, LLC [BIOMERIEUX SA] | FilmArray NGDS Warrior Panel | 2017-10-19 |
BioFire Defense, LLC [BIOMERIEUX SA] | FilmArray NGDS Warrior Panel | 2017-10-19 |
BioFire Defense, LLC | FilmArray NGDS Warrior Panel | 2017-06-22 |
BioFire Defense, LLC | FilmArray NGDS Warrior Panel | 2017-02-14 |
BioFire Defense, LLC [BIOMERIEUX SA] | JBAIDS Q Fever Detection Kit | 2016-03-01 |
BioFire Defense, LLC [BIOMERIEUX SA] | JBAIDS Anthrax Detection Kit | 2016-03-01 |
BioFire Defense, LLC [BIOMERIEUX SA] | FilmArray 2.0 | 2015-02-18 |
BioFire Defense, LLC [BIOMERIEUX SA] | JBAIDS Tularemia Detection Kit | 2014-10-24 |
BioFire Defense, LLC [BIOMERIEUX SA] | JBAIDS Anthrax Detection Kit | 2014-10-24 |
BioFire Defense, LLC [BIOMERIEUX SA] | JBAIDS Plague Detection Kit | 2014-10-24 |
BioFire Defense, LLC [BIOMERIEUX SA] | JBAIDS Plague Detection Kit | 2014-10-24 |
BioFire Defense, LLC [BIOMERIEUX SA] | JBAIDS Tularemia Detection Kit | 2014-10-24 |
BioFire Defense, LLC [BIOMERIEUX SA] | JBAIDS Anthrax Detection System | 2014-10-24 |
| NCAGE Code | 088J2 | BIOFIRE DEFENSE, LLC |
| CAGE Code | 088J2 | BIOFIRE DEFENSE, LLC |
| S.A.M. Registration | 088J2 [556915205] | BIOFIRE DEFENSE, LLC |