FDA.reportPublic FDA data

FilmArray® BCID Panel

Primary DI
00815381020093
Brand
FilmArray® BCID Panel
Company
BIOFIRE DIAGNOSTICS, LLC
Model
RFIT-ASY-0127
Catalog number
RFIT-ASY-0127
Device description
IVD reagent kit containing 6 tests.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System
PAMGram-Positive Bacteria And Their Resistance Markers
PENGram-Negative Bacteria And Associated Resistance Markers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
PAMGram-Positive Bacteria And Their Resistance MarkersMicrobiology2
PENGram-Negative Bacteria And Associated Resistance MarkersMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130914000FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELBiofire Diagnostics, Inc.2013-06-21PEN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815381020093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815381020093008153810200938153810200930815381020093

GMDN Terms#

Term, Definition table
TermDefinition
Multiple bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry method.

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
00850028489017MyrnaInflammatix, Inc.OOI2026-04-30
00850028489024TriVerityInflammatix, Inc.OOI2026-04-30
00875197005240cobas® Cdiff TestRoche Molecular Systems, Inc.OOI2026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor KitRoche Molecular Systems, Inc.OOI2026-02-24
00875197005677cobas® CdiffRoche Molecular Systems, Inc.OOI2026-02-23
00875197005684cobas® Cdiff Control KitRoche Molecular Systems, Inc.OOI2026-02-23
10816101025142LIAISON NES® InstrumentDIASORIN MOLECULAR LLCOOI2026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCOOI2026-01-22
07332940009694GeneXpert®CEPHEIDOOI2026-01-19
07332940009700GeneXpert® XpressCEPHEIDOOI2026-01-19
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCOOI2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCOOI2026-01-14
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448721BD Enteric Bacterial Panel plus for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904452797Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
06955792701717Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-11-19
06955792701670Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-10-16
15420045517486Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517493Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517509Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517516Panther Fusion®Hologic, Inc.OOI2025-10-07
06955792700857Q-Vera Pico 6X qPCR InstrumentSansure Biotech Inc.OOI2025-09-18
04053228041849QIAstat-Dx® RiseQIAGEN GmbHOOI2025-09-05
07332940009687GeneXpert®CEPHEIDOOI2025-08-15
00811877012153ID NOW InstrumentAlere Scarborough, Inc.OOI2025-08-01
00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONPAM2025-07-11
00840487101841LIAISON PLEX Gram-Negative Blood Culture AssayLUMINEX CORPORATIONPEN2025-06-11