BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DIRECT LDL-CHOLESTEROL (LDL)

    DI: 05055273208450 · Model: CH8032 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DIRECT LDL-CHOLESTEROL (LDL)
    Primary DI
    05055273208450
    Version / Model
    CH8032
    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
    5ef4ea6d-28ee-4828-a2f4-f0e0be40eb4c

    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
    MRR System, Test, Low Density, Lipoprotein

    GMDN Terms

    Code Name
    53395 Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 05055273208450