FDA.reportPublic FDA data

ePlex

Primary DI
00857167005306
Brand
ePlex
Company
GENMARK DIAGNOSTICS, INC.
Model
BCID-GN Cartridge Pouch
Catalog number
KT021836
Device description
ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch
Published
2019-08-22
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
K182619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182619000ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated2019-04-12PEN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857167005306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857167005306008571670053068571670053060857167005306

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gram negative bacteria species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of gram negative bacteria belonging to the Enterobacteriaceae or non-Enterobacteriaceae families, that have been isolated by culture from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962104217
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857167005009ePlexePlex System Base2018-05-21
00857167005023ePlex SystemePlex Respiratory Panel (RP)KT0220062018-01-03
00857167005030ePlex SystemePlex Respiratory Panel (RP)EA0010122017-12-29
00857167005092eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)KT0216202016-09-24
00857167005108eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)MT0051002016-09-24
00857167005115eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)MT0051012016-09-24
00857167005122eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)MT0051012016-09-24
00857167005139eSensor® XT-8eSensor® Respiratory Viral Panel (RVP)MT0051012016-09-24
00857167005047eSensor® XT-8Warfarin Sensitivity Test (WST)KT0205912016-09-24
00857167005061eSensor® XT-8Warfarin Sensitivity Test (WST)MT0020002016-09-24
00857167005146eSensor® XT-8eSensor® Cystic Fibrosis (CF)KT0206572016-09-24
00857167005153eSensor® XT-8eSensor® Cystic Fibrosis (CF)MT0020152016-09-24
00857167005160eSensor® XT-8eSensor® Cystic Fibrosis (CF) MT0020142016-09-24
00857167005177eSensor® XT-8eSensor® Cystic Fibrosis (CF)MT0020142016-09-24
00857167005184eSensor® XT-8eSensor® Cystic Fibrosis (CF)MT0020142016-09-24
00857167005191eSensor® XT-8eSensor® Thrombophilia Risk Test (TRT)KT0210532016-09-24
00857167005207eSensor® XT-8eSensor® Thrombophilia Risk Test (TRT)MT0040132016-09-24
00857167005214eSensor® XT-8eSensor® Thrombophilia Risk Test (TRT)MT0040082016-09-24
00857167005221eSensor® XT-8eSensor® Thrombophilia Risk Test (TRT)MT0040082016-09-24
00857167005238eSensor® XT-8eSensor® Thrombophilia Risk Test Reagent Test (TRTMT0040082016-09-24

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, LLCPAM2025-02-18
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPEO2025-02-18
00815381020345BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPEN2025-02-18
00840487101865LIAISON PLEX Yeast Blood Culture Assay KitLUMINEX CORPORATIONPEO2024-10-22
00815381020338BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPEN2020-07-02
00815381020338BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPEO2020-07-02
00815381020338BioFire® Blood Culture Identification 2 (BCID2) PanelBIOFIRE DIAGNOSTICS, LLCPAM2020-07-02
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.PEO2019-08-22
00857167005283ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005283ePlexGENMARK DIAGNOSTICS, INC.PAM2019-08-22
00857167005290ePlexGENMARK DIAGNOSTICS, INC.PEO2019-08-22
00857167005290ePlexGENMARK DIAGNOSTICS, INC.PEN2019-08-22
00857167005290ePlexGENMARK 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