BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STA® - Fibrinogen 5

    DI: 13607450006749 · Model: 00674 · DIAGNOSTICA STAGO
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    12

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    Basic Information

    Brand Name
    STA® - Fibrinogen 5
    Primary DI
    13607450006749
    Version / Model
    00674
    Company Name
    DIAGNOSTICA STAGO
    Labeler DUNS
    262277122
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    12
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    5
    Public Version Date
    2024-02-26
    Public Version Status
    Update
    Public Device Record Key
    4c3d6a53-9441-42bb-869a-e2dfefae36d2

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KQJ SYSTEM, FIBRINOGEN DETERMINATION

    GMDN Terms

    Code Name
    55997 Fibrinogen assay (factor I) IVD, kit, clotting

    Identifiers

    Type ID
    Primary 13607450006749
    Unit of Use 03607450006742

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius