FDA.reportPublic FDA data

BioFire® Blood Culture Identification 2 (BCID2) Panel

Primary DI
00815381020338
Brand
BioFire® Blood Culture Identification 2 (BCID2) Panel
Company
BIOFIRE DIAGNOSTICS, LLC
Model
RFIT-ASY-0147
Device description
IVD reagent kit containing 30 tests.
Published
2020-07-02
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
PAMGram-Positive Bacteria And Their Resistance Markers
PENGram-Negative Bacteria And Associated Resistance Markers
PEOFungal Organisms, Nucleic Acid-Based Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAMGram-Positive Bacteria And Their Resistance MarkersMicrobiology2
PENGram-Negative Bacteria And Associated Resistance MarkersMicrobiology2
PEOFungal Organisms, Nucleic Acid-Based AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193519000
K243759000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193519000BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC2020-03-18PEN
K243759000BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLC2024-12-20PEN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815381020338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815381020338008153810203388153810203380815381020338

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
00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONPAM2025-07-11
00840487101841LIAISON PLEX Gram-Negative Blood Culture AssayLUMINEX CORPORATIONPEN2025-06-11
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPEN2025-02-18
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPEO2025-02-18
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPAM2025-02-18
00840487101865LIAISON PLEX Yeast Blood Culture Assay KitLUMINEX CORPORATIONPEO2024-10-22
00840487101575Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONPAM2019-12-05
00840487101599Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test CartridgeLUMINEX CORPORATIONPEN2019-12-05
00840487101629Gram-Positive Blood Culture (BC-GP) Extraction TrayLUMINEX CORPORATIONPAM2019-12-05
00840487101643Gram-Negative Blood Culture (BC-GN) Extraction TrayLUMINEX CORPORATIONPEN2019-12-05
00840487101674Gram-Positive Blood Culture (BC-GP) Utility TrayLUMINEX CORPORATIONPAM2019-12-05
00840487101698Gram-Negative Blood Culture (BC-GN) Utility TrayLUMINEX CORPORATIONPEN2019-12-05
00857167005283ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005283ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005283ePlexGENMARK DIAGNOSTICS, INC.PEO2019-08-22
00857167005290ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005290ePlexGENMARK DIAGNOSTICS, INC.PEO2019-08-22
00857167005290ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005306ePlexGENMARK DIAGNOSTICS, INC.PEO2019-08-22
00857167005306ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005306ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005313ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005313ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005313ePlexGENMARK DIAGNOSTICS, INC.PEO2019-08-22
00857167005320ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005320ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005320ePlexGENMARK DIAGNOSTICS, INC.PEO2019-08-22
00857167005337ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005337ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005337ePlexGENMARK DIAGNOSTICS, INC.PEO2019-08-22