BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NxTAG Respiratory Pathogen Panel

    Reg #: 1650733 · FEI: 3002524000 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Luminex Corporation
    Registration Number
    1650733
    FEI Number
    3002524000
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12212 Technology Blvd
    City
    AUSTIN
    State
    TX
    ZIP
    78727
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152386

    Owner / Operator

    Firm Name
    Luminex Corporation
    Operator Number
    9032042
    Address
    12212 Technology Blvd.
    City
    Austin
    State
    TX
    Postal Code
    78727
    Country
    US
    Correspondent
    Mari Meyer

    Products

    Device Name Product Code
    Respiratory Virus Panel Nucleic Acid Assay System OCC

    Proprietary Names

    NxTAG Respiratory Pathogen Panel

    Establishment Types

    Manufacture Medical Device