BioFire Diagnostics, LLC

FDA Filings

This page includes the latest FDA filings for BioFire Diagnostics, LLC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
BioFire Diagnostics, LLC
BioFire Blood Culture Identification 2 (BCID2) Panel2020-03-18
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel Plus2018-11-15
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel2018-11-09
BioFire Diagnostics, LLC
FilmArray Blood Culture Identification (BCID) Panel2018-07-05
BioFire Diagnostics, LLC
FilmArray Respiratory Panel 2 (RP2)2017-05-30
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
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
FilmArray Respiratory Panel (RP) For Use With FilmArray Torch2016-02-08
BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel For Use With The FilmArray 2.02015-02-19
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
FILMARRAY GASTROINTESTINAL (GI) PANEL2014-05-02
BIOFIRE DIAGNOSTICS, INC.
JBAIDS ANTHRAX DETECTION KIT2013-08-05
BIOFIRE DIAGNOSTICS, INC.
JBAIDS PLAGUE DETECTION KIT2013-07-31
BIOFIRE DIAGNOSTICS, INC.
JBAIDS TULAREMIA DETECTION KIT2013-07-31
BIOFIRE DIAGNOSTICS, INC.
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL2013-06-21
BIOFIRE DIAGNOSTICS, INC.
FILMARRAY RESPIRATORY PANEL (RP)2013-02-11

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
BioFire Diagnostics, LLC
FilmArray Respiratory Panel 2 Plus (RP2plus)2017-11-24
BioFire Diagnostics, LLC
FilmArray Meningitis/Encephalitis(ME) Panel2015-10-08

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
FilmArray® Pneumonia Panel plus (Pneumoplus)
BIOFIRE DIAGNOSTICS, LLC2019-01-14
FilmArray® Pneumonia Panel plus (Pneumoplus)
BIOFIRE DIAGNOSTICS, LLC2019-01-14
FilmArray® Pneumonia Panel (Pneumo)
BIOFIRE DIAGNOSTICS, LLC2019-01-14
FilmArray® Pneumonia Panel (Pneumo)
BIOFIRE DIAGNOSTICS, LLC2019-01-14
FilmArray® Meningitis/Encephalitis (ME) Panel
BIOFIRE DIAGNOSTICS, LLC2018-08-08
FilmArray® Meningitis/Encephalitis (ME) Panel
BIOFIRE DIAGNOSTICS, LLC2018-08-08
FilmArray® Gastrointestinal (GI) Panel
BIOFIRE DIAGNOSTICS, LLC2018-08-08
FilmArray® Gastrointestinal (GI) Panel
BIOFIRE DIAGNOSTICS, LLC2018-08-08
FilmArray® BCID Panel
BIOFIRE DIAGNOSTICS, LLC2018-08-08
FilmArray® BCID Panel
BIOFIRE DIAGNOSTICS, LLC2018-08-08
FilmArray® Respiratory Panel (RP)
BIOFIRE DIAGNOSTICS, LLC2018-08-08
FilmArray® Respiratory Panel (RP)
BIOFIRE DIAGNOSTICS, LLC2018-08-08
FilmArray® Respiratory Panel 2 plus (RP2plus)
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Respiratory Panel 2 plus (RP2plus)
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Torch Module
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Torch Module
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Torch System Base
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Torch System Base
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Respiratory Panel 2 (RP2)
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Respiratory Panel 2 (RP2)
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Respiratory Panel (RP) EZ
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® 2.0 Instrument
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® 2.0 Instrument
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Instrument
BIOFIRE DIAGNOSTICS, LLC2018-07-06
FilmArray® Instrument
BIOFIRE DIAGNOSTICS, LLC2018-07-06

Related Finance Registrations
Legal Entity Identifier 549300BOOARFT1K7KE79 [BIOFIRE DIAGNOSTICS, LLC]

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