FilmArray® BCID Panel RFIT-ASY-0126

GUDID 00815381020086

IVD reagent kit containing 30 tests.

BIOFIRE DIAGNOSTICS, LLC

Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
Primary Device ID00815381020086
NIH Device Record Keyb944bfdd-2aed-429f-bb12-69d86315ec0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilmArray® BCID Panel
Version Model NumberRFIT-ASY-0126
Catalog NumberRFIT-ASY-0126
Company DUNS079280262
Company NameBIOFIRE DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815381020086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOIReal Time Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-08
Device Publish Date2016-09-23

On-Brand Devices [FilmArray® BCID Panel]

00815381020093IVD reagent kit containing 6 tests.
00815381020086IVD reagent kit containing 30 tests.

Trademark Results [FilmArray]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FILMARRAY
FILMARRAY
85939258 4554601 Live/Registered
BioFire Diagnostics, Inc.
2013-05-22
FILMARRAY
FILMARRAY
77083897 3761522 Live/Registered
BIOFIRE DIAGNOSTICS, LLC
2007-01-16

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