FDA.reportPublic FDA data

ePlex System

Primary DI
00857167005016
Brand
ePlex System
Company
GENMARK DIAGNOSTICS, INC.
Model
ePlex Respiratory Panel (RP)
Catalog number
KT022287
Device description
Respiratory Panel Cartridge
Published
2018-01-03
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
OCCRespiratory Virus Panel Nucleic Acid Assay System
OEMHuman Metapneumovirus (Hmpv) Rna Assay System
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
OOUParainfluenza Multiplex Nucleic Acid Assay
OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
OZXMycoplasma Pneumoniae Dna Assay System
OZYChlamydophila Pneumoniae Dna Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OEMHuman Metapneumovirus (Hmpv) Rna Assay SystemMicrobiology2
OEPInfluenza A Virus Subtype Differentiation Nucleic Acid AssayMicrobiology2
OOUParainfluenza Multiplex Nucleic Acid AssayMicrobiology2
OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And IdentificationMicrobiology2
OTGNon-Sars Coronavirus Multiplex Nucleic Acid AssayMicrobiology2
OZEInfluenza A And Influenza B Multiplex Nucleic Acid AssayMicrobiology2
OZXMycoplasma Pneumoniae Dna Assay SystemMicrobiology2
OZYChlamydophila Pneumoniae Dna Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163636000ePlex Respiratory Pathogen PanelGenmark Diagnostics, Incorporated2017-06-09OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857167005016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857167005016008571670050168571670050160857167005016

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory virus antigen IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antigens from viruses associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962104217
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
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
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00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCOZE2024-07-26
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOTG2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZX2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOEM2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOOU2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZE2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOCC2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZY2024-05-03
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOZE2023-05-09
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOTG2023-05-09
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2023-05-09
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZY2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZX2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOCC2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZE2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOTG2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOOU2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOEM2023-04-06
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00851034007073BioCode Respiratory Pathogen PanelAPPLIED BIOCODE, INC.OCC2020-01-10
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