BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gamma ELU-Kit II

    Reg #: 1034569 · FEI: 1034569 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMMUCOR, INC.
    Registration Number
    1034569
    FEI Number
    1034569
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3130 GATEWAY DR.
    City
    Norcross
    State
    GA
    ZIP
    30071
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK830014

    Owner / Operator

    Firm Name
    IMMUCOR, INC.
    Operator Number
    1034569
    Address
    3130 GATEWAY DR.
    City
    Norcross
    State
    GA
    Postal Code
    30071
    Country
    US

    Products

    Device Name Product Code
    Media, Potentiating For In Vitro Diagnostic Use KSG

    Proprietary Names

    Gamma ELU-Kit II

    Establishment Types

    Manufacture Medical Device