FDA.reportPublic FDA data

FilmArray® Gastrointestinal (GI) Panel

Primary DI
00815381020116
Brand
FilmArray® Gastrointestinal (GI) Panel
Company
BIOFIRE DIAGNOSTICS, LLC
Model
RFIT-ASY-0104
Catalog number
RFIT-ASY-0104
Device description
IVD reagent kit containing 6 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
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140407000
K143005000
K160459000
K230404000
K242367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140407000FILMARRAY GASTROINTESTINAL (GI) PANELBiofire Diagnostics2014-05-02PCH
K143005000FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC2015-02-19PCH
K160459000FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC2016-04-01PCH
K230404000BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC2023-03-16PCH
K242367000BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC2024-11-07PCH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815381020116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815381020116008153810201168153810201160815381020116

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840487101438LIAISON PLEX Gastrointestinal Flex AssayLUMINEX CORPORATIONPCH2026-06-08
07332940009489XpertCEPHEIDPCH2026-01-30
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
00382904448721BD Enteric Bacterial Panel plus for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
15420045517486Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517493Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517509Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517516Panther Fusion®Hologic, Inc.PCH2025-10-07
04053228048381QIAstat-Dx® GI Panel 2 Mini BQIAGEN GmbHPCH2025-03-28
00815381020888BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidBIOFIRE DIAGNOSTICS, LLCPCH2025-02-18
00815381020963BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidBIOFIRE DIAGNOSTICS, LLCPCH2025-02-18
04053228049166QIAstat-Dx® GI Panel 2 Mini B&VQIAGEN GmbHPCH2025-02-18
09351179004070EasyScreen™ Gastrointestinal Parasite PCR Positive ControlGENETIC SIGNATURES LIMITEDPCH2024-06-18
04053228043249QIAstat-Dx® Gastrointestinal Panel 2QIAGEN GmbHPCH2024-06-17
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYPCH2024-06-07
00382904431594BD Pre-warm HeaterBECTON, DICKINSON AND COMPANYPCH2024-03-19
00382904439859BD MAX™ Enteric Viral PanelBECTON, DICKINSON AND COMPANYPCH2020-02-19
00840487101520Enteric Pathogens (EP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONPCH2019-12-05
00840487101544Enteric Pathogens (EP) Amplification TrayLUMINEX CORPORATIONPCH2019-12-05
00840487101551Enteric Pathogens (EP) Extraction TrayLUMINEX CORPORATIONPCH2019-12-05
00840487101568Enteric Pathogens (EP) Stool Sample Preparation KitLUMINEX CORPORATIONPCH2019-12-05
00382904438128BD MAX™ Extended Enteric Bacterial PanelBECTON, DICKINSON AND COMPANYPCH2019-01-03
00851034007004BioCode MDx 3000APPLIED BIOCODE, INC.PCH2018-10-15
00851034007011Gastrointestinal Pathogen Panel (GPP) KitAPPLIED BIOCODE, INC.PCH2018-10-15
07332940000974Xpert NorovirusCEPHEIDPCH2018-01-29
B178GBSBPP100Stool Bacterial Pathogens PanelGREAT BASIN SCIENTIFIC, INC.PCH2017-07-24
00382904429607BD MAX™ Enteric Parasite PanelBECTON, DICKINSON AND COMPANYPCH2016-10-17
00382904429638BD MAX™ Enteric Bacterial PanelBECTON, DICKINSON AND COMPANYPCH2016-10-17
B178GBSTEC100Shiga Toxin Direct TestGREAT BASIN SCIENTIFIC, INC.PCH2016-09-23