BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lipoprint LDL Subfractions Kit 4x25 tests

    DI: 00896863002332 · Model: 48-7002 · QUANTIMETRIX CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lipoprint LDL Subfractions Kit 4x25 tests
    Primary DI
    00896863002332
    Version / Model
    48-7002
    Catalog Number
    48-7002
    Company Name
    QUANTIMETRIX CORPORATION
    Labeler DUNS
    010717890
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-26
    Public Version
    1
    Public Version Date
    2018-10-29
    Public Version Status
    New
    Public Device Record Key
    907035e6-b24e-4670-afae-c11dd17003a7

    Device Description

    The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions from VLDL to HDL) in fasting serum or plasma with a Total Cholesterol concentration of >100mg/dL. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment, and clinical evaluation.

    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
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)
    JHO Electrophoretic Separation, Lipoproteins

    GMDN Terms

    Code Name
    31523 Total lipoprotein IVD, control

    Identifiers

    Type ID
    Secondary M05148700215
    Primary 00896863002332

    Customer Contacts

    Phone
    (310) 536-0006
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K010337 000
    K013662 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius