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 Number: 3002773840
• FEI Number: 3002773840
• Name: BioFire Diagnostics, 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: 515 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	Device	Date
GUDID 00815381020727 BIOFIRE DIAGNOSTICS, LLC	BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini	2024-08-05
GUDID 00815381020390 BIOFIRE DIAGNOSTICS, LLC	BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel	2024-05-13
GUDID 00815381020765 BIOFIRE DIAGNOSTICS, LLC	BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini	2023-05-17
GUDID 00815381020659 BIOFIRE DIAGNOSTICS, LLC	BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel	2023-04-14
GUDID 00815381020376 BIOFIRE DIAGNOSTICS, LLC	BIOFIRE ® SPOTFIRE ® Module	2023-04-14
GUDID 00815381020369 BIOFIRE DIAGNOSTICS, LLC	BIOFIRE ® SPOTFIRE ® Module	2023-04-14
GUDID 00815381020352 BIOFIRE DIAGNOSTICS, LLC	BIOFIRE ® SPOTFIRE ® Control Station	2023-04-14
GUDID 00815381020055 BIOFIRE DIAGNOSTICS, LLC	BIOFIRE ® SPOTFIRE ® Control Station	2023-04-14
PMN K222601 BioFire Diagnostics, LLC	FilmArray Pneumonia Panel Plus	2022-10-27
GUDID 00815381020192 BIOFIRE DIAGNOSTICS, LLC	BioFire® Joint Infection (JI) Panel	2022-07-08
De Novo DEN200066 BioFire Diagnostics, LLC	BioFire Joint Infection (JI) Panel	2022-04-29
PMN K212727 BioFire Diagnostics, LLC	FilmArray Pneumonia Panel	2021-09-22
GUDID 00815381029089 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Torch Module	2021-06-29
GUDID 00815381029072 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Torch System Base	2021-06-29
GUDID 00815381029058 BIOFIRE DIAGNOSTICS, LLC	FilmArray® 2.0 Instrument	2021-06-29
GUDID 00815381020529 BIOFIRE DIAGNOSTICS, LLC	BioFire® Respiratory Panel 2.1	2021-04-21
De Novo DEN200031 Biofire Diagnostics, LLC	BioFire Respiratory Panel 2.1 (RP2.1)	2021-03-17
GUDID 00815381020482 BIOFIRE DIAGNOSTICS, LLC	BioFire® Respiratory Panel 2.1 EUA	2020-12-03
GUDID 00815381020239 BIOFIRE DIAGNOSTICS, LLC	BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests	2020-12-03
GUDID 00815381020338 BIOFIRE DIAGNOSTICS, LLC	BioFire® Blood Culture Identification 2 (BCID2) Panel	2020-07-10
QJR BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire COVID-19 Test	2020-03-31
PMN K193519 | PEO BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Blood Culture Identification 2 Panel	2020-03-24
PMN K193519 | PEO BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Blood Culture Identification 2 (BCID2) Panel	2020-03-24
PMN K193519 | PEO BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire BCID2 Panel	2020-03-24
PMN K193519 | PEN BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Blood Culture Identification 2 Panel	2020-03-24
PMN K193519 | PEN BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Blood Culture Identification 2 (BCID2) Panel	2020-03-24
PMN K193519 | PEN BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire BCID2 Panel	2020-03-24
PMN K193519 | PAM BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Blood Culture Identification 2 Panel	2020-03-24
PMN K193519 | PAM BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Blood Culture Identification 2 (BCID2) Panel	2020-03-24
PMN K193519 | PAM BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire BCID2 Panel	2020-03-24
PMN K193519 BioFire Diagnostics, LLC	BioFire Blood Culture Identification 2 (BCID2) Panel	2020-03-18
GUDID 00815381020321 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Pneumonia Panel plus (Pneumoplus)	2019-01-14
GUDID 00815381020314 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Pneumonia Panel plus (Pneumoplus)	2019-01-14
GUDID 00815381020185 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Pneumonia Panel (Pneumo)	2019-01-14
GUDID 00815381020178 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Pneumonia Panel (Pneumo)	2019-01-14
PMN K181324 | QDS BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Pneumonia Plus Panel	2018-11-19
PMN K181324 | QDS BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Pneumo plus Panel	2018-11-19
PMN K181324 | QDS BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire FilmArray Pneumonia plus Panel	2018-11-19
PMN K181324 BioFire Diagnostics, LLC	FilmArray Pneumonia Panel Plus	2018-11-15
PMN K180966 | QBH BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Pneumonia Panel	2018-11-14
PMN K180966 | QBH BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire Pneumo Panel	2018-11-14
PMN K180966 | QBH BioFire Diagnostics, LLC [BIOMERIEUX SA]	BioFire FilmArray Pneumonia Panel	2018-11-14
PMN K180966 BioFire Diagnostics, LLC	FilmArray Pneumonia Panel	2018-11-09
GUDID 00815381020130 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0119	2018-08-08
GUDID 00815381020123 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0118	2018-08-08
GUDID 00815381020116 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104	2018-08-08
GUDID 00815381020109 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116	2018-08-08
GUDID 00815381020093 BIOFIRE DIAGNOSTICS, LLC	FilmArray® BCID Panel RFIT-ASY-0127	2018-08-08
GUDID 00815381020086 BIOFIRE DIAGNOSTICS, LLC	FilmArray® BCID Panel RFIT-ASY-0126	2018-08-08
GUDID 00815381020079 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Respiratory Panel (RP) RFIT-ASY-0125	2018-08-08
GUDID 00815381020062 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Respiratory Panel (RP) RFIT-ASY-0124	2018-08-08
PMN K181493 | PEN BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Blood Culture Identification Panel	2018-07-23
PMN K181493 | PEN BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray BCID Panel	2018-07-23
PMN K181493 | PAM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Blood Culture Identification Panel	2018-07-23
PMN K181493 | PAM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray BCID Panel	2018-07-23
GUDID 00815381020307 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Respiratory Panel 2 plus (RP2plus) RFIT-ASY-0137	2018-07-06
GUDID 00815381020291 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Respiratory Panel 2 plus (RP2plus) RFIT-ASY-0136	2018-07-06
GUDID 00815381020284 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Torch Module HTFA-SUB-0103R	2018-07-06
GUDID 00815381020277 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Torch Module HTFA-SUB-0103	2018-07-06
GUDID 00815381020260 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Torch System Base HTFA-ASY-0104R	2018-07-06
GUDID 00815381020253 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Torch System Base HTFA-ASY-0104	2018-07-06
GUDID 00815381020161 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Respiratory Panel 2 (RP2) RFIT-ASY-0130	2018-07-06
GUDID 00815381020154 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Respiratory Panel 2 (RP2) RFIT-ASY-0129	2018-07-06
GUDID 00815381020147 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Respiratory Panel (RP) EZ RFIT-ASY-0120	2018-07-06
GUDID 00815381020048 BIOFIRE DIAGNOSTICS, LLC	FilmArray® 2.0 Instrument FLM2-ASY-0001R	2018-07-06
GUDID 00815381020031 BIOFIRE DIAGNOSTICS, LLC	FilmArray® 2.0 Instrument FLM2-ASY-0001	2018-07-06
GUDID 00815381020024 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Instrument FLM1-ASY-0001R	2018-07-06
GUDID 00815381020017 BIOFIRE DIAGNOSTICS, LLC	FilmArray® Instrument FLM1-ASY-0001	2018-07-06
PMN K181493 BioFire Diagnostics, LLC	FilmArray Blood Culture Identification (BCID) Panel	2018-07-05
PMN DEN170017 | PZF BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2 plus	2017-11-30
PMN DEN170017 | PZF BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2plus	2017-11-30
PMN DEN170017 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2 plus	2017-11-30
PMN DEN170017 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2plus	2017-11-30
PMN DEN170017 | NSU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2 plus	2017-11-30
PMN DEN170017 | NSU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2plus	2017-11-30
De Novo DEN170017 BioFire Diagnostics, LLC	FilmArray Respiratory Panel 2 Plus (RP2plus)	2017-11-24
PMN K170604 | OZZ BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2	2017-05-31
PMN K170604 | OZZ BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2	2017-05-31
PMN K170604 | OZY BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2	2017-05-31
PMN K170604 | OZY BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2	2017-05-31
PMN K170604 | OZX BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2	2017-05-31
PMN K170604 | OZX BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2	2017-05-31
PMN K170604 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2	2017-05-31
PMN K170604 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2	2017-05-31
PMN K170604 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2	2017-05-31
PMN K170604 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2	2017-05-31
PMN K170604 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2	2017-05-31
PMN K170604 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2	2017-05-31
PMN K170604 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2	2017-05-31
PMN K170604 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2	2017-05-31
PMN K170604 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel 2	2017-05-31
PMN K170604 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP2	2017-05-31
PMN K170604 BioFire Diagnostics, LLC	FilmArray Respiratory Panel 2 (RP2)	2017-05-30
PMN K152579 | OZZ BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OZY BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OZX BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OQW BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray RP EZ for use with FilmArray 2.0 EZ Configuration	2016-10-10
PMN K152579 BIOFIRE DIAGNOSTICS, LLC	FilmArray Respiratory Panel EZ (RP EZ)	2016-10-03
PMN K160459 BIOFIRE DIAGNOSTICS, LLC	FilmArray Gastrointestinal Panel (GI) For Use With FilmArray Torch	2016-04-01
PMN K160459 | PCH BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray GI Panel for use with FilmArray Torch	2016-04-01
PMN K160462 | PLO BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray ME Panel for use on FilmArray Torch	2016-03-21
PMN K160462 BIOFIRE DIAGNOSTICS, LLC	FilmArray Meningitis/Encephalitis (ME) Panel For Use With FilmArray Torch	2016-03-17
PMN K160457 BIOFIRE DIAGNOSTICS, LLC	FilmArray Blood Culture Identification (BCID) Panel For Use With FilmArray Torch	2016-03-15
PMN K160457 | PEN BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray BCID Panel for use with FilmArray Torch	2016-03-15
PMN K160457 | PAM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray BCID Panel for use with FilmArray Torch	2016-03-15
PMN K160457 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray BCID Panel for use with FilmArray Torch	2016-03-15
PMN K160068 | OZZ BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (RP) For Use With FilmArray Torch	2016-03-07
PMN K160068 | OZX BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (RP) For Use With FilmArray Torch	2016-03-07
PMN K160068 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (RP) For Use With FilmArray Torch	2016-03-07
PMN K160068 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (RP) For Use With FilmArray Torch	2016-03-07
PMN K160068 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (RP) For Use With FilmArray Torch	2016-03-07
PMN K160068 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (RP) For Use With FilmArray Torch	2016-03-07
PMN K160068 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (RP) For Use With FilmArray Torch	2016-03-07
PMN K160068 BioFire Diagnostics, LLC	FilmArray Respiratory Panel (RP) For Use With FilmArray Torch	2016-02-08
PMN DEN150013 | PLO BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Meningitis/Encephalitis (ME) Panel	2015-11-04
PMN DEN150013 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Meningitis/Encephalitis (ME) Panel	2015-11-04
PMN DEN150013 | NSU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Meningitis/Encephalitis (ME) Panel	2015-11-04
De Novo DEN150013 BioFire Diagnostics, LLC	FilmArray Meningitis/Encephalitis(ME) Panel	2015-10-08
PMN K143171 | PEN BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Blood Culture Identification (BCID) Panel	2015-02-25
PMN K143171 | PAM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Blood Culture Identification (BCID) Panel	2015-02-25
PMN K143171 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Blood Culture Identification (BCID) Panel	2015-02-25
PMN K143080 | OZZ BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OZY BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OZX BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OQW BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143080 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Respiratory Panel (RP)	2015-02-25
PMN K143005 | PCH BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray? Gastrointestinal (GI) Panel	2015-02-25
PMN K143005 BioFire Diagnostics, LLC	FilmArray Gastrointestinal (GI) Panel For Use With The FilmArray 2.0	2015-02-19
PMN K143178 | NSU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray 2.0	2015-02-18
PMN K143080 BioFire Diagnostics, LLC	FilmArray Respiratory Panel (RP) For Use With Multi-instrument FilmArray System	2015-02-17
PMN K143178 BioFire Diagnostics, LLC	FilmArray 2.0 System	2015-01-30
PMN K143171 Biofire Diagnostics, LLC.	FilmArray Blood Culture Identification (BCID) Panel For Use With The FilmArray 2.0	2015-01-30
PMN K140407 | PCH BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Gastrointestinal (GI) Panel	2014-10-24
PMN K130914 | PEO BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Blood Culture Identification (BCID) Panel	2014-10-24
PMN K130914 | PEN BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Blood Culture Identification (BCID) Panel	2014-10-24
PMN K130914 | PAM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Blood Culture Identification (BCID) Panel	2014-10-24
PMN K130914 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Blood Culture Identification (BCID) Panel	2014-10-24
PMN K123620 | OZZ BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OZY BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OZX BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OQW BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K123620 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OZZ BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OZY BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OZX BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K120267 | NXD BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K110764 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K110764 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K110764 | OOI BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K110764 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K110764 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K110764 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K110764 | NXD BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K103175 | OTG BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K103175 | OOU BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K103175 | OEP BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K103175 | OEM BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K103175 | OCC BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24
PMN K103175 | NXD BioFire Diagnostics, LLC [BIOMERIEUX SA]	FilmArray Respiratory Panel (Rp)	2014-10-24

Related Finance Registrations

NCAGE Code	72GV2	BIOFIRE DIAGNOSTICS, LLC
CAGE Code	72GV2	BIOFIRE DIAGNOSTICS, LLC
S.A.M. Registration	72GV2 [79280262]	BIOFIRE DIAGNOSTICS, LLC