BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Liposure Serum Lipoprotein Control Level 1 4x0.5mL

    DI: 00896863002318 · Model: 48-7060 · QUANTIMETRIX CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Liposure Serum Lipoprotein Control Level 1 4x0.5mL
    Primary DI
    00896863002318
    Version / Model
    48-7060
    Catalog Number
    48-7060
    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
    e40280b0-beae-4f39-b9ac-632530de6cc0

    Device Description

    The Liposure Lipoprotein Control is intended for monitoring lipoprotein fractions (VLDL to HDL) as well as subfractions (Mid-bands, LDL subfractions 1, 2, and 3) using the Lipoprint LDL System to validate the separation and quantitation of lipoproteins in patient serum samples. It is prepared from human serum and supplied lyophilized. The lyophilized material contains stabilizers and preservatives.

    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 M05148706019
    Primary 00896863002318

    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