BEUDAMED
    FDA Registration Active 🇺🇸 United States

    cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel

    Reg #: 3008632402 · FEI: 3008632402 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    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
    K182690

    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
    Fungal Organisms, Nucleic Acid-Based Assay PEO
    Gram-Positive Bacteria And Their Resistance Markers PAM
    Gram-Negative Bacteria And Associated Resistance Markers PEN

    Proprietary Names

    cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel

    Establishment Types

    Manufacture Medical Device