BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    pts panels® HDL Cholesterol Controls

    DI: 00381930722010 · Model: 722 · POLYMER TECHNOLOGY SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    pts panels® HDL Cholesterol Controls
    Primary DI
    00381930722010
    Version / Model
    722
    Catalog Number
    722
    Company Name
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Labeler DUNS
    835772872
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-18
    Public Version
    4
    Public Version Date
    2023-01-23
    Public Version Status
    Update
    Public Device Record Key
    28fcfc11-ff68-43cb-96b7-93186cc88f86

    Device Description

    PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with each set of controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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 00381930722010

    Customer Contacts

    Phone
    +1(888)877-5610
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K022401 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not freeze.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Use care not to contaminate dropper tip.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Product is ready to use and is clear.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Recap after using.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Opened product is stable for at least ten months at room temperature.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Do not use beyond the expiration date on the vial.
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    20 – 30 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    68 – 86 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    35 – 46 Degrees Fahrenheit