BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LDL Cholesterol Reagent Set

    DI: 00812137012074 · Model: R1 x 2 x 70mL, R2 x 1 x 50mL · CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    LDL Cholesterol Reagent Set
    Primary DI
    00812137012074
    Version / Model
    R1 x 2 x 70mL, R2 x 1 x 50mL
    Catalog Number
    501-420
    Company Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Labeler DUNS
    048144997
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2016-10-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    e589da2e-e125-48e0-add2-f8e08c9d7678

    Device Description

    The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    53409 Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry

    Identifiers

    Type ID
    Primary 00812137012074
    Unit of Use 00812137012340

    Customer Contacts

    Phone
    8004533328
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius