BEUDAMED
    FDA Registration Active 🇺🇸 United States

    hema-screen

    Reg #: 2244821 · FEI: 2244821 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IMMUNOSTICS, INC.
    Registration Number
    2244821
    FEI Number
    2244821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    38 Industrial Way E Ste 1
    City
    Eatontown
    State
    NJ
    ZIP
    07724
    Country
    US

    Regulatory Submissions

    510(k) Number
    K902360

    Owner / Operator

    Firm Name
    IMMUNOSTICS, INC.
    Operator Number
    2244821
    Address
    38 INDUSTRIAL WAY EAST, SUITE 1, --
    City
    Eatontown
    State
    NJ
    Postal Code
    07724
    Country
    US
    Correspondent
    Young Mi Kim

    Products

    Device Name Product Code
    Reagent, Occult Blood KHE

    Proprietary Names

    hema-screen

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198