BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Multi-Analyte Lipid Control Set

    DI: 00812137012197 · Model: L1 x 3mL, L2 x 3mL, L3 x 3mL · CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    Multi-Analyte Lipid Control Set
    Primary DI
    00812137012197
    Version / Model
    L1 x 3mL, L2 x 3mL, L3 x 3mL
    Catalog Number
    502-160
    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
    3
    Public Version Date
    2022-03-08
    Public Version Status
    Update
    Public Device Record Key
    d14530a9-ca5f-4851-931c-ef53c4160255

    Device Description

    This product is intended for in-vitro use in the quality control of HDL, LDL, Apolipoprotein A-1, Apolipoprotein B, and Lipopro-tein (a) methods on clinical chemistry systems. The Multi-Analyte Lipid Control Set is a set of three serum levels. These three levels are to be used exclusively with the CDS HDL Cholesterol Reagent, CDS LDL Cholesterol Reagent, (CDS 501-419 and CDS 501-420) which are assays for the quan-tification of various lipids and lipoproteins in human serum.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    Yes
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    44695 High density lipoprotein (HDL) cholesterol IVD, control

    Identifiers

    Type ID
    Primary 00812137012197
    Unit of Use 00812137012418

    Customer Contacts

    Phone
    8004533328
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius