BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PTS Panels® HDL Cholesterol Test Strips

    DI: 00381931788015 · Model: 1788 · POLYMER TECHNOLOGY SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    PTS Panels® HDL Cholesterol Test Strips
    Primary DI
    00381931788015
    Version / Model
    1788
    Catalog Number
    1788
    Company Name
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Labeler DUNS
    835772872
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2016-07-22
    Public Version
    5
    Public Version Date
    2023-07-31
    Public Version Status
    Update
    Public Device Record Key
    7b89f007-7a1d-464d-9c33-c40a3ab13740

    Device Description

    PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    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
    NAQ LIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER

    GMDN Terms

    Code Name
    53393 High density lipoprotein (HDL) cholesterol IVD, reagent

    Identifiers

    Type ID
    Primary 00381931788015
    Unit of Use 10381931788012

    Customer Contacts

    Phone
    +1(877)870-5610
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K060617 000
    K070017 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight Keep dry
    Type
    Storage Environment Temperature
    Temperature Range
    68 – 86 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    20 – 30 Degrees Celsius