BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Clungene COVID-19 IgM/IgG Rapid Test Cassette

    Reg #: 3015259874 · FEI: 3015259874 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PELLECOME LLC
    Registration Number
    3015259874
    FEI Number
    3015259874
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    240 Main Street, Bldg A, Suite 1
    City
    Gladstone
    State
    NJ
    ZIP
    07934
    Country
    US

    Owner / Operator

    Firm Name
    Pellecome LLC
    Operator Number
    10059229
    Address
    240 Main Street
    City
    Gladstone
    State
    NJ
    Postal Code
    07934
    Country
    US
    Correspondent
    Melissa Vinci-Rainis

    Products

    Device Name Product Code
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    Clungene COVID-19 IgM/IgG Rapid Test Cassette Livzon Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility