BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HDL-CHOLESTEROL (HDL)

    DI: 05055273201161 · Model: CH203 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    HDL-CHOLESTEROL (HDL)
    Primary DI
    05055273201161
    Version / Model
    CH203
    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
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    8ed415a3-5b11-4577-833b-d5c8828741ca

    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
    LBR Ldl & Vldl Precipitation, Hdl

    GMDN Terms

    Code Name
    53391 High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 05055273201161