BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    N-geneous LDL Cholesterol Reagent (R1)

    DI: 00628063400690 · Model: 80-4604-00 · SEKISUI DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N-geneous LDL Cholesterol Reagent (R1)
    Primary DI
    00628063400690
    Version / Model
    80-4604-00
    Catalog Number
    80-4604-00
    Company Name
    SEKISUI DIAGNOSTICS, LLC
    Labeler DUNS
    966812344
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    3
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    7122f111-c05a-4556-858e-59c763cf971b
    Distribution End Date
    2016-10-24

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    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
    53395 Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00628063400690