BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Colorzyme ANA Test System

    Reg #: 2918768 · FEI: 2918768 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMMUNO CONCEPTS, NA, Ltd.
    Registration Number
    2918768
    FEI Number
    2918768
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9825 Goethe Rd Ste 350
    City
    SACRAMENTO
    State
    CA
    ZIP
    95827
    Country
    US

    Regulatory Submissions

    510(k) Number
    K833148

    Owner / Operator

    Firm Name
    Immuno Concepts
    Operator Number
    2918768
    Address
    9825 Goethe Road, Suite 350
    City
    Sacramento
    State
    CA
    Postal Code
    95827
    Country
    US
    Correspondent
    Nicole L Lasquete

    Products

    Device Name Product Code
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM

    Proprietary Names

    Colorzyme ANA Test System

    Establishment Types

    Manufacture Medical Device