BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Yumizen C1200 Level 1 CRPhs Control

    DI: 03610230009284 · Model: 1300071247 · HORIBA ABX SAS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Yumizen C1200 Level 1 CRPhs Control
    Primary DI
    03610230009284
    Version / Model
    1300071247
    Company Name
    HORIBA ABX SAS
    Labeler DUNS
    273647420
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-02
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    761e9a5f-07fc-43de-9b23-f973b95bd3a5

    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    41839 C-reactive protein (CRP) IVD, control

    Identifiers

    Type ID
    Primary 03610230009284