FDA.reportPublic FDA data

FilmArray® Meningitis/Encephalitis (ME) Panel

Primary DI
00815381020123
Brand
FilmArray® Meningitis/Encephalitis (ME) Panel
Company
BIOFIRE DIAGNOSTICS, LLC
Model
RFIT-ASY-0118
Catalog number
RFIT-ASY-0118
Device description
IVD reagent kit containing 30 tests.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems
OOIReal Time Nucleic Acid Amplification System
PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN150013000
K160462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150013000FilmArray Meningitis/Encephalitis(ME) PanelBiofire Diagnostics, LLC2015-10-08PLO
K160462000FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchBiofire Diagnostics, LLC2016-03-17PLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815381020123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815381020123008153810201238153810201230815381020123

GMDN Terms#

Term, Definition table
TermDefinition
Multiple meningitis-associated microorganism nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple microorgnamisms associated with meningitis, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2). ), varicella-zoster virus (VZV), and Mumps virus.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079280262
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini4245372024-07-26
00815381020055BIOFIRE ® SPOTFIRE ® Control StationFAST-ASY-00012023-04-06
00815381020352BIOFIRE ® SPOTFIRE ® Control StationFAST-ASY-0001-W2023-04-06
00815381020369BIOFIRE ® SPOTFIRE ® ModuleFAST-ASY-00022023-04-06
00815381020376BIOFIRE ® SPOTFIRE ® ModuleFAST-ASY-0002-W2023-04-06
00815381029058FilmArray® 2.0 InstrumentFLM2-ASY-0001-W2021-06-21
00815381029072FilmArray® Torch System BaseHTFA-ASY-0001-W2021-06-21
00815381029089FilmArray® Torch ModuleHTFA-ASY-0003-W2021-06-21
00815381020017FilmArray® InstrumentFLM1-ASY-0001FLM1-ASY-00012016-09-23
00815381020024FilmArray® InstrumentFLM1-ASY-0001FLM1-ASY-0001R2016-09-23
00815381020031FilmArray® 2.0 InstrumentFLM2-ASY-0001FLM2-ASY-00012016-09-23
00815381020048FilmArray® 2.0 InstrumentFLM2-ASY-0001FLM2-ASY-0001R2016-09-23
00815381020253FilmArray® Torch System BaseHTFA-ASY-0104HTFA-ASY-01042016-08-01
00815381020260FilmArray® Torch System BaseHTFA-ASY-0104HTFA-ASY-0104R2016-09-23
00815381020277FilmArray® Torch ModuleHTFA-SUB-0103HTFA-SUB-01032016-08-10
00815381020284FilmArray® Torch ModuleHTFA-SUB-0103HTFA-SUB-0103R2016-09-23
00815381020208BioFire® Joint Infection (JI) PanelRFIT-ASY-01352025-02-18
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelRFIT-ASY-01482025-02-18
00815381020888BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid4248982025-02-18
00815381020963BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid4250892025-02-18

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