FDA.reportPublic FDA data

ePlex System

Primary DI
00857167005030
Brand
ePlex System
Company
GENMARK DIAGNOSTICS, INC.
Model
ePlex Respiratory Panel (RP)
Catalog number
EA001012
Device description
ePlex Respiratory Panel Kit, 12 test, IVD
Published
2017-12-29
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
00857167005030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857167005030008571670050308571670050300857167005030

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
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

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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