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

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal pathogen 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 multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

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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