Biofire Defense L L C

FDA Filings

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.

FDA Registration(s)
Registration Number3010770794
FEI Number3010770794
NameBioFire Defense, LLC
Owner & OperatorBIOMERIEUX SA
Contact AddressCHEMIN DE L'ORME --
MARCY L'ETOILE FR-NOTA 69280 FR
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address79 W 4500 S Ste 14
Salt Lake City, UT 84107 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
BIOFIRE DEFENSE, LLC
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel DFA2-ASY-00062021-07-26
BIOFIRE DEFENSE, LLC
BioFire® Global Fever Panel DFA2-ASY-00042021-07-26
BioFire Defense, LLC
FilmArray Global Fever Panel External Control Kit2020-11-20
BioFire Defense, LLC
FilmArray Global Fever Panel2020-11-20
BioFire Defense, LLC [BIOMERIEUX SA]
BioFire COVID-19 Test2020-03-31
BIOFIRE DEFENSE, LLC
JBAIDS JRPD-ASY-01362020-02-12
BIOFIRE DEFENSE, LLC
JBAIDS JRPD-ASY-01382020-02-12
BIOFIRE DEFENSE, LLC
JBAIDS JRPD-ASY-01372020-02-12
BIOFIRE DEFENSE, LLC
FilmArray® NGDS Warrior Panel NGDS-ASY-00072019-08-02
BIOFIRE DEFENSE, LLC
NGDS NGDS-ASY-00062019-08-02
BIOFIRE DEFENSE, LLC
FilmArray® 2.0 Instrument NGDS Configuration NGDS-ASY-00042018-07-06
BIOFIRE DEFENSE, LLC
FilmArray® 2.0 Instrument NGDS Configuration NGDS-ASY-0002U2018-07-06
BIOFIRE DEFENSE, LLC
FILMARRAY FLM1-ASY-01212018-07-06
BIOFIRE DEFENSE, LLC
FilmArray® 2.0 Instrument NGDS Configuration NGDS-ASY-00022018-07-06
BIOFIRE DEFENSE, LLC
JBAIDS JRPD-ASY-01232018-07-06
BIOFIRE DEFENSE, LLC
JBAIDS JRPD-ASY-01162018-07-06
BIOFIRE DEFENSE, LLC
JBAIDS JRPD-ASY-01242018-07-06
BIOFIRE DEFENSE, LLC
JBAIDS JRPD-ASY-00162018-07-06
BIOFIRE DEFENSE, LLC
JBAIDS JRPD-ASY-00012018-07-06
BioFire Defense, LLC [BIOMERIEUX SA]
FilmArray NGDS Warrior Panel2017-10-19
BioFire Defense, LLC [BIOMERIEUX SA]
FilmArray NGDS Warrior Panel2017-10-19
BioFire Defense, LLC
FilmArray NGDS Warrior Panel2017-06-22
BioFire Defense, LLC
FilmArray NGDS Warrior Panel2017-02-14
BioFire Defense, LLC [BIOMERIEUX SA]
JBAIDS Q Fever Detection Kit2016-03-01
BioFire Defense, LLC [BIOMERIEUX SA]
JBAIDS Anthrax Detection Kit2016-03-01
BioFire Defense, LLC [BIOMERIEUX SA]
FilmArray 2.02015-02-18
BioFire Defense, LLC [BIOMERIEUX SA]
JBAIDS Tularemia Detection Kit2014-10-24
BioFire Defense, LLC [BIOMERIEUX SA]
JBAIDS Anthrax Detection Kit2014-10-24
BioFire Defense, LLC [BIOMERIEUX SA]
JBAIDS Plague Detection Kit2014-10-24
BioFire Defense, LLC [BIOMERIEUX SA]
JBAIDS Plague Detection Kit2014-10-24
BioFire Defense, LLC [BIOMERIEUX SA]
JBAIDS Tularemia Detection Kit2014-10-24
BioFire Defense, LLC [BIOMERIEUX SA]
JBAIDS Anthrax Detection System2014-10-24

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