BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ePlex Respiratory Pathogen (RP) Panel

    Reg #: 3008632402 · FEI: 3008632402 · Expires 2025
    View on FDA
    Products
    10
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    GENMARK DIAGNOSTICS, INC.
    Registration Number
    3008632402
    FEI Number
    3008632402
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GenMark Diagnostics, Inc., 5964 La Place Ct
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163636

    Owner / Operator

    Firm Name
    GenMark Diagnostics, Inc.
    Operator Number
    9056858
    Address
    GenMark Diagnostics, Inc., 5964 La Place Ct
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Alan B Maderazo

    Products

    Device Name Product Code
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG
    Chlamydophila Pneumoniae Dna Assay System OZY
    Mycoplasma Pneumoniae Dna Assay System OZX
    Instrumentation For Clinical Multiplex Test Systems NSU
    Influenza A Virus Subtype Differentiation Nucleic Acid Assay OEP
    Parainfluenza Multiplex Nucleic Acid Assay OOU
    2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification OQW

    Proprietary Names

    ePlex Respiratory Pathogen (RP) Panel cobas® eplex respiratory pathogen (RP) panel

    Establishment Types

    Manufacture Medical Device