BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    sLDL CONTROL - LEVEL 1 (sLDL CONTROL 1)

    DI: 05055273209075 · Model: LE5013 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    sLDL CONTROL - LEVEL 1 (sLDL CONTROL 1)
    Primary DI
    05055273209075
    Version / Model
    LE5013
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-03
    Public Version
    1
    Public Version Date
    2019-06-11
    Public Version Status
    New
    Public Device Record Key
    68e4cf30-d860-4997-b84f-464be2498f64

    Device Characteristics

    Single Use
    Yes
    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
    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
    53411 Dense low density lipoprotein (DLDL) cholesterol IVD, control

    Identifiers

    Type ID
    Primary 05055273209075