BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Anti-Endomysial Antibody (EMA) Test

    Reg #: 3015376545 · FEI: 3015376545 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMMCO DIAGNOSTICS, INC.
    Registration Number
    3015376545
    FEI Number
    3015376545
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 Earhart Drive, --
    City
    Williamsville
    State
    NY
    ZIP
    14221
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060157

    Owner / Operator

    Firm Name
    IMMCO DIAGNOSTICS, INC.
    Operator Number
    1315336
    Address
    10 EARHART DR., --
    City
    Buffalo
    State
    NY
    Postal Code
    14221
    Country
    US
    Correspondent
    Lee Kroening

    Products

    Device Name Product Code
    Autoantibodies, Endomysial(Tissue Transglutaminase) MVM

    Proprietary Names

    Anti-Endomysial Antibody (EMA) Test

    Establishment Types

    Manufacture Medical Device