BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENMARK DIAGNOSTICS, INC.

    Reg #: 3008632402 · FEI: 3008632402 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    GENMARK DIAGNOSTICS, INC.
    Registration Number
    3008632402
    FEI Number
    3008632402
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    GenMark Diagnostics, Inc., 5964 La Place Ct
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181663

    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
    Jeff Boone

    Products

    Device Name Product Code
    Gram-Positive Bacteria And Their Resistance Markers PAM
    Fungal Organisms, Nucleic Acid-Based Assay PEO
    Gram-Negative Bacteria And Associated Resistance Markers PEN
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Instrumentation For Clinical Multiplex Test Systems NSU
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Chlamydophila Pneumoniae Dna Assay System OZY
    Parainfluenza Multiplex Nucleic Acid Assay OOU
    Mycoplasma Pneumoniae Dna Assay System OZX
    Influenza A Virus Subtype Differentiation Nucleic Acid Assay OEP
    2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification OQW

    Proprietary Names

    ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel cobas® eplex blood culture identification gram positive (BCID-GP) panel cobas® eplex respiratory pathogen panel 3 ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel cobas® eplex blood culture identification gram negative (BCID-GN) panel ePlex SARS-CoV-2 Test ePlex Respiratory Pathogen Panel 2 cobas® eplex respiratory pathogen panel 2 GenMark ePlex Instrument cobas® eplex system ePlex Respiratory Pathogen (RP) Panel cobas® eplex respiratory pathogen (RP) panel

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only