BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)

    Reg #: 3006028115 · FEI: 3006028115 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Luminex Corporation
    Registration Number
    3006028115
    FEI Number
    3006028115
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4088 Commercial Avenue
    City
    Northbrook
    State
    IL
    ZIP
    60062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132843

    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
    Instrumentation For Clinical Multiplex Test Systems NSU
    Gram-Negative Bacteria And Associated Resistance Markers PEN

    Proprietary Names

    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)

    Establishment Types

    Manufacture Medical Device