BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Diazyme

    DI: 00817089023512 · Model: 06U9510 · DIAZYME LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Diazyme
    Primary DI
    00817089023512
    Version / Model
    06U9510
    Company Name
    DIAZYME LABORATORIES, INC.
    Labeler DUNS
    080507219
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-22
    Public Version
    1
    Public Version Date
    2025-10-30
    Public Version Status
    New
    Public Device Record Key
    fd8f11cb-4894-4e9a-95ee-b0a6cac35c54

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    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
    DFH Kappa, Antigen, Antiserum, Control
    DEH Lambda, Antigen, Antiserum, Control

    GMDN Terms

    Code Name
    41431 Kappa/lambda light chain immunoglobulin IVD, control

    Identifiers

    Type ID
    Primary 00817089023512