BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    AESKUSLIDES ® ANA HEp-2-Gamma

    Reg #: 3003825930 · FEI: 3003825930 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AESKU.DIAGNOSTICS GmbH&Co.KG
    Registration Number
    3003825930
    FEI Number
    3003825930
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MIKROFORUM RING 2
    City
    WENDELSHEIM Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K153117

    Owner / Operator

    Firm Name
    Aesku.Diagnostics GmbH & Co. KG
    Operator Number
    9057973
    Address
    MIKROFORUM RING 2, --
    City
    WENDELSHEIM
    State
    Rhineland-Palatinate
    Postal Code
    55234
    Country
    DE

    US Agent

    Business Name
    Bion Enterprises, Ltd.
    Contact Name
    Nadine Shabat
    Address
    455 State Street, Suite 100
    City
    Des Plaines
    State
    IL
    ZIP
    60016
    Country
    US
    Email
    [email protected]
    Phone
    847 5445044 ext. 2149

    Products

    Device Name Product Code
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN

    Proprietary Names

    AESKUSLIDES ® ANA HEp-2-Gamma HELIOS® AUTOMATED IFA SYSTEM (IOS-1000)

    Establishment Types

    Manufacture Medical Device