FDA.reportPublic FDA data

BioFire Defense, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107707943010770794BioFire Defense, LLC1N2026-01-0179 W 4500 S Ste 14 Salt Lake City UT US 84107

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851458005266FILMARRAY NGDS WARRIOR PANEL - CA - FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)801-262-3592support@biofiredefense.com
00851458005273BioFire® Global Fever Special Pathogens Panel - BioFire® Global Fever Special Pathogens Panel - IVD reagent kit containing 6 tests801-262-3592support@biofiredefense.com
00851458005280BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane - BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit801-262-3592support@biofiredefense.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1757581311150654K243822BioFire Warrior Panel; BioFire Warrior Panel Control KitPRD2025-03-12
1757581217784364K221460BioFire COVID-19 Test 2QQX2022-07-25
1757581854477242K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelQMV2022-10-20
1757581437642539K213954BIOFIRE SPOTFIRE Respiratory (R) PanelQOF2023-02-03
1757581642273186K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelQVR2023-03-22
1757581655496745K211079BioFire COVID-19 Test 2QQX2021-11-01
1757581513660914K202382FilmArray Global Fever Panel External Control KitPMN2020-11-20
1757581535477204K170883FilmArray NGDS Warrior PanelPRD2017-06-22
1757581535209722K143178FilmArray 2.0 SystemNSU2015-01-30
1757581733131645K131936JBAIDS TULAREMIA DETECTION KITOEH2013-07-31
1757581310724571K131930JBAIDS ANTHRAX DETECTION KITNHT2013-08-05
1757581516326907K131729JBAIDS PLAGUE DETECTION KITOIH2013-07-31
1757581979431399K103207JBAIDS Q FEVER DETECTION KITOVF2011-05-20
1757581984140677K072631JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123NHT2007-12-20
1757581215873501K072547JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124OEH2007-12-19
1757581069411035K071188MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEMNHT2007-05-21
1757582059860650K051713JBAIDS ANTHRAC DETECTION SYSTEMNHT2005-11-18
1757581453790186DEN200043FilmArray Global Fever PanelQMV2020-11-20
1757581419722653
1757581805100034
1757581822931117

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHT42013-08-05
PRD22025-03-12
QMV22022-10-20
QQX22022-07-25
OEH22013-07-31
QVR12023-03-22
QOF12023-02-03
PMN12020-11-20
NSU12015-01-30
OIH12013-07-31
OVF12011-05-20

PMN#

GUDID#