FDA.reportPublic FDA data

ePlex

Primary DI
00857167005009
Brand
ePlex
Company
GENMARK DIAGNOSTICS, INC.
Model
ePlex System Base
Device description
Instrumentation for clinical multiplex test systems
Published
2018-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163652000ePlex InstrumentGenmark Diagnostics, Incorporated2017-06-09NSU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857167005009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857167005009008571670050098571670050090857167005009

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)A mains electricity (AC-powered) automated laboratory instrument intended to determine the sequence of nucleotides in a nucleic acid library [pre-constructed from deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for genetic analysis of a clinical specimen, using a next-generation sequencing (NGS) technique. It consists of a detector (e.g., fluorescent, luminescent or electrochemical) which detects signals from incorporated nucleotides, as well as sample processing, data processing, and/or data display software. It operates with minimal technician input and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962104217
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00857167005245eSensor® XT-8Warfarin Sensitivity Test (WST)MT0020012016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00851458005334SPOTFIRE Control Station - non-ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONNSU2025-07-11
08033891322670CHORUS EVODIESSE DIAGNOSTICA SENESE SPANSU2025-07-01
00840487101841LIAISON PLEX Gram-Negative Blood Culture AssayLUMINEX CORPORATIONNSU2025-06-11
04719880531103QLociLIFEOS GENOMICS CORPORATIONNSU2025-04-30
00850063063005DASH® Rapid PCR InstrumentNuclein, LLCNSU2025-01-06
00856826006203Applied BiosystemsAffymetrix, Inc.NSU2024-12-24
15420045517059Aptima®Hologic, Inc.NSU2024-12-19
15420045517066Aptima®Hologic, Inc.NSU2024-12-19
15420045517073Aptima®Hologic, Inc.NSU2024-12-19
15420045517080Aptima®Hologic, Inc.NSU2024-12-19
06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCNSU2024-07-26
00840487101957LIAISON PLEX® ChassisLUMINEX CORPORATIONNSU2024-06-20
00840487101964LIAISON PLEX® Chassis (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
00840487101988LIAISON PLEX® Module (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00875197006926cobas Buffer Negative Control KitRoche Diagnostics GmbHNSU2024-06-05
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCNSU2024-05-03
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYNSU2024-04-02
00851458005297FILMARRAY® COMMERCIAL LAPTOPBIOFIRE DEFENSE, LLCNSU2024-03-19
00195126000871Aptiva® System Cleaning Solution KitINOVA DIAGNOSTICS, INC.NSU2024-03-18
00195126000741Aptiva® Instrument System CuvettesINOVA DIAGNOSTICS, INC.NSU2024-03-11