Biofire Diagnostics L L C

FDA Filings

This page includes the latest FDA filings for Biofire Diagnostics 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 Number3002773840
FEI Number3002773840
NameBioFire Diagnostics, 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 Address515 Colorow Drive
Salt Lake City, UT 84108 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
BIOFIRE DIAGNOSTICS, LLC
BioFire® Respiratory Panel 2.1 2021-04-21
Biofire Diagnostics, LLC
BioFire Respiratory Panel 2.1 (RP2.1)2021-03-17
BIOFIRE DIAGNOSTICS, LLC
BioFire® Respiratory Panel 2.1 EUA 2020-12-03
BIOFIRE DIAGNOSTICS, LLC
BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests 2020-12-03
BIOFIRE DIAGNOSTICS, LLC
BioFire® Blood Culture Identification 2 (BCID2) Panel 2020-07-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire COVID-19 Test2020-03-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Blood Culture Identification 2 Panel2020-03-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Blood Culture Identification 2 (BCID2) Panel2020-03-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire BCID2 Panel2020-03-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Blood Culture Identification 2 Panel2020-03-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Blood Culture Identification 2 (BCID2) Panel2020-03-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire BCID2 Panel2020-03-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Blood Culture Identification 2 Panel2020-03-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Blood Culture Identification 2 (BCID2) Panel2020-03-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire BCID2 Panel2020-03-24
BioFire Diagnostics, LLC
BioFire Blood Culture Identification 2 (BCID2) Panel2020-03-18
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Pneumonia Panel plus (Pneumoplus) 2019-01-14
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Pneumonia Panel plus (Pneumoplus) 2019-01-14
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Pneumonia Panel (Pneumo) 2019-01-14
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Pneumonia Panel (Pneumo) 2019-01-14
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Pneumonia Plus Panel2018-11-19
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Pneumo plus Panel2018-11-19
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire FilmArray Pneumonia plus Panel2018-11-19
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel Plus2018-11-15
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Pneumonia Panel2018-11-14
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire Pneumo Panel2018-11-14
BioFire Diagnostics, LLC [BIOMERIEUX SA]
BioFire FilmArray Pneumonia Panel2018-11-14
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel2018-11-09
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-01192018-08-08
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-01182018-08-08
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-01042018-08-08
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-01162018-08-08
BIOFIRE DIAGNOSTICS, LLC
FilmArray® BCID Panel RFIT-ASY-01272018-08-08
BIOFIRE DIAGNOSTICS, LLC
FilmArray® BCID Panel RFIT-ASY-01262018-08-08
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Respiratory Panel (RP) RFIT-ASY-01252018-08-08
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Respiratory Panel (RP) RFIT-ASY-01242018-08-08
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Blood Culture Identification Panel2018-07-23
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray BCID Panel2018-07-23
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Blood Culture Identification Panel2018-07-23
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray BCID Panel2018-07-23
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Respiratory Panel 2 plus (RP2plus) RFIT-ASY-0137 2018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Respiratory Panel 2 plus (RP2plus) RFIT-ASY-01362018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Torch Module HTFA-SUB-0103R2018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Torch Module HTFA-SUB-01032018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Torch System Base HTFA-ASY-0104R2018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Torch System Base HTFA-ASY-01042018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Respiratory Panel 2 (RP2) RFIT-ASY-01302018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Respiratory Panel 2 (RP2) RFIT-ASY-01292018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Respiratory Panel (RP) EZ RFIT-ASY-01202018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® 2.0 Instrument FLM2-ASY-0001R2018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® 2.0 Instrument FLM2-ASY-00012018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Instrument FLM1-ASY-0001R2018-07-06
BIOFIRE DIAGNOSTICS, LLC
FilmArray® Instrument FLM1-ASY-00012018-07-06
BioFire Diagnostics, LLC
FilmArray Blood Culture Identification (BCID) Panel2018-07-05
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 2 plus2017-11-30
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP2plus2017-11-30
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 2 plus2017-11-30
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP2plus2017-11-30
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 2 plus2017-11-30
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP2plus2017-11-30
BioFire Diagnostics, LLC
FilmArray Respiratory Panel 2 Plus (RP2plus)2017-11-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel 22017-05-31
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP22017-05-31
BioFire Diagnostics, LLC
FilmArray Respiratory Panel 2 (RP2)2017-05-30
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration2016-10-10
BIOFIRE DIAGNOSTICS, LLC
FilmArray Respiratory Panel EZ (RP EZ)2016-10-03
BIOFIRE DIAGNOSTICS, LLC
FilmArray Gastrointestinal Panel (GI) For Use With FilmArray Torch2016-04-01
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray GI Panel for use with FilmArray Torch2016-04-01
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray ME Panel for use on FilmArray Torch2016-03-21
BIOFIRE DIAGNOSTICS, LLC
FilmArray Meningitis/Encephalitis (ME) Panel For Use With FilmArray Torch2016-03-17
BIOFIRE DIAGNOSTICS, LLC
FilmArray Blood Culture Identification (BCID) Panel For Use With FilmArray Torch2016-03-15
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray BCID Panel for use with FilmArray Torch2016-03-15
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray BCID Panel for use with FilmArray Torch2016-03-15
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray BCID Panel for use with FilmArray Torch2016-03-15
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-03-07
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-03-07
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-03-07
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-03-07
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-03-07
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-03-07
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-03-07
BioFire Diagnostics, LLC
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-02-08
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Meningitis/Encephalitis (ME) Panel2015-11-04
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Meningitis/Encephalitis (ME) Panel2015-11-04
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Meningitis/Encephalitis (ME) Panel2015-11-04
BioFire Diagnostics, LLC
FilmArray Meningitis/Encephalitis(ME) Panel2015-10-08
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Blood Culture Identification (BCID) Panel2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Blood Culture Identification (BCID) Panel2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Blood Culture Identification (BCID) Panel2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Respiratory Panel (RP)2015-02-25
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray? Gastrointestinal (GI) Panel2015-02-25
BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel For Use With The FilmArray 2.02015-02-19
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray 2.02015-02-18
BioFire Diagnostics, LLC
FilmArray Respiratory Panel (RP) For Use With Multi-instrument FilmArray System2015-02-17
BioFire Diagnostics, LLC
FilmArray 2.0 System2015-01-30
Biofire Diagnostics, LLC.
FilmArray Blood Culture Identification (BCID) Panel For Use With The FilmArray 2.02015-01-30
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Gastrointestinal (GI) Panel2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Blood Culture Identification (BCID) Panel2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Blood Culture Identification (BCID) Panel2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Blood Culture Identification (BCID) Panel2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Blood Culture Identification (BCID) Panel2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24
BioFire Diagnostics, LLC [BIOMERIEUX SA]
FilmArray Respiratory Panel (Rp)2014-10-24

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