BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Diazyme

    DI: 00817089020528 · Model: DZ179A-K · DIAZYME LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Diazyme
    Primary DI
    00817089020528
    Version / Model
    DZ179A-K
    Company Name
    DIAZYME LABORATORIES, INC.
    Labeler DUNS
    080507219
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-03
    Public Version
    3
    Public Version Date
    2026-01-21
    Public Version Status
    Update
    Public Device Record Key
    97a8e67c-14f0-4f82-af4d-e0afef471542

    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
    GHH Fibrin Split Products

    GMDN Terms

    Code Name
    47346 D-dimer IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 00817089020528

    Premarket Submissions

    Submission Number Supplement Number
    K112120 000