FilmArray® Meningitis/Encephalitis (ME) Panel RFIT-ASY-0119

GUDID 00815381020130

IVD reagent kit containing 6 tests.

BIOFIRE DIAGNOSTICS, LLC

Multiple meningitis-associated microorganism nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00815381020130
NIH Device Record Keyb8e67541-affd-4aa0-8841-4eb027a63894
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilmArray® Meningitis/Encephalitis (ME) Panel
Version Model NumberRFIT-ASY-0119
Catalog NumberRFIT-ASY-0119
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
GS100815381020130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection 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® Meningitis/Encephalitis (ME) Panel]

00815381020130IVD reagent kit containing 6 tests.
00815381020123IVD 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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