FDA.report

BioFire Diagnostics, LLC

Matched from indexed company URL: Biofire Diagnostics, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30027738403002773840BioFire Diagnostics, LLC1N2026-01-01515 Colorow Drive Salt Lake City UT US 84108

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1757561092152794K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH2025-01-16
1757561675811793K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))PEN2024-12-20
1757561678120386K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF2025-08-14
1757561822931117K243463BIOFIRE FILMARRAY Tropical Fever PanelQMV2024-12-05
1757562023902544K243222BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)QDS2024-11-06
1757561043317367K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH2024-11-07
1757561272391577K241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniQOF2024-05-30
1757561593122172K232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelQOF2024-03-26
1757561650476669K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniQOF2023-04-13
1757561249288440K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH2023-03-16
1757561897707731K222601FilmArray Pneumonia Panel plusQDS2022-10-27
1757561437642539K213954BIOFIRE SPOTFIRE Respiratory (R) PanelQOF2023-02-03
1757561887083505K212727FilmArray Pneumonia PanelQDP2021-09-22
1757561438969175K193519BioFire Blood Culture Identification 2 (BCID2) PanelPEN2020-03-18
1757561813806814K181493FilmArray Blood Culture Identification (BCID) PanelPEN2018-07-05
1757561268673054K181324FilmArray Pneumonia Panel plusQDS2018-11-15
1757561052137654K180966FilmArray Pneumonia PanelQDP2018-11-09
1757561849503663K170604FilmArray Respiratory Panel 2 (RP2)OCC2017-05-30
1757561352208301K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchPLO2016-03-17
1757561130190516K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchPCH2016-04-01
1757561125934108K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchPEN2016-03-15
1757561028784755K160068FilmArray Respiratory Panel (RP) for use with FilmArray TorchOCC2016-02-08
1757561770982176K152579FilmArray Respiratory Panel EZ (RP EZ)OCC2016-10-03
1757561535209722K143178FilmArray 2.0 SystemNSU2015-01-30
1757561286714000K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0PEN2015-01-30
1757561017920521K143080FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray SystemOCC2015-02-17
1757561222798957K143005FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0PCH2015-02-19
1757561205065156K140407FILMARRAY GASTROINTESTINAL (GI) PANELPCH2014-05-02
1757561852113687K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELPEN2013-06-21
1757561126102829K123620FILMARRAY RESPIRATORY PANEL (RP)OCC2013-02-11
1757561125661624K120267FILMARRAY RP PANELOCC2012-05-15
1757561053439472K110764FILMARRAY RP PANELOCC2011-04-27
1757561954359139K103175FILMARRAY RESPIRATORY PANEL (RP)OCC2011-02-17
1757561273261672DEN200066BioFire Joint Infection (JI) PanelQSN2022-04-29
1757561280671507DEN200031BioFire Respiratory Panel 2.1 (RP2.1)QOF2021-03-17
1757561170301421DEN170017FilmArray Respiratory Panel 2 plus (RP2plus)PZF2017-11-24
1757561409258231DEN150013FilmArray Meningitis/Encephalitis(ME) PanelPLO2015-10-08
1757561419722653
1757561584537041

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
OCC82017-05-30
QOF62025-08-14
PCH62025-01-16
PEN62024-12-20
QDS32024-11-06
QDP22021-09-22
PLO22016-03-17
QMV12024-12-05
QSN12022-04-29
PZF12017-11-24
NSU12015-01-30

PMN

GUDID

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