BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Yumizen C1200 L2 Cystatin C Control

    DI: 03610230007945 · Model: 1300023953 · HORIBA ABX SAS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Yumizen C1200 L2 Cystatin C Control
    Primary DI
    03610230007945
    Version / Model
    1300023953
    Company Name
    HORIBA ABX SAS
    Labeler DUNS
    273647420
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-14
    Public Version
    1
    Public Version Date
    2020-09-22
    Public Version Status
    New
    Public Device Record Key
    12cb257c-9326-415a-b0c9-62f2034c78c3

    Device Characteristics

    Single Use
    Yes
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    48175 Cystatin C IVD, control

    Identifiers

    Type ID
    Primary 03610230007945