BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Albumin ELISA

    DI: 04050598163300 · Model: K 6330 · Immundiagnostik AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Albumin ELISA
    Primary DI
    04050598163300
    Version / Model
    K 6330
    Company Name
    Immundiagnostik AG
    Labeler DUNS
    321663841
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-21
    Public Version
    2
    Public Version Date
    2025-08-18
    Public Version Status
    Update
    Public Device Record Key
    f3e16775-6a4e-4546-bac4-6aa38cf8e73e

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DCF Albumin, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    53598 Albumin IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04050598163300

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius