BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Diazyme

    DI: 90817089020002 · Model: DZ142A-K · DIAZYME LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Diazyme
    Primary DI
    90817089020002
    Version / Model
    DZ142A-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
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    1421956c-341e-4c88-a596-2e7909e4a598

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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

    GMDN Terms

    Code Name
    53447 Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

    Identifiers

    Type ID
    Primary 90817089020002