BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    PTS Detect® Cotinine System

    DI: 00381933061017 · Model: 3061 · POLYMER TECHNOLOGY SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    PTS Detect® Cotinine System
    Primary DI
    00381933061017
    Version / Model
    3061
    Catalog Number
    3061
    Company Name
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Labeler DUNS
    835772872
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2018-10-08
    Public Version
    3
    Public Version Date
    2022-04-13
    Public Version Status
    Update
    Public Device Record Key
    46bf859e-f067-4c4c-9f6d-e5438c4e8d44
    Distribution End Date
    2020-02-01

    Device Description

    Cotinine, the major metabolite of nicotine, indicates exposure to tobacco and other nicotine-containing products. Cotinine has a longer half-life than nicotine, which allows for a more accurate assessment of smoking or exposure status and better monitoring of progress in smoking cessation programs.1 Because of its longer half-life and relative ease of detection, cotinine is the choice metabolite to assess exposure to nicotine. The amount of cotinine present in the blood is proportional to the amount and recency of nicotine exposure. The PTS Detect cotinine system provides measurement of cotinine in capillary (fingerstick) or venous whole blood.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    MRS Test system, nicotine, cotinine, metabolites

    GMDN Terms

    Code Name
    55579 Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00381933061017
    Unit of Use 10381933061014

    Customer Contacts

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

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Leave all components in their sealed pouches until use.
    Type
    Special Storage Condition, Specify
    Special Conditions
    If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
    Type
    Special Storage Condition, Specify
    Special Conditions
    If refrigerated, ensure components are at room temperature prior to use.
    Type
    Special Storage Condition, Specify
    Special Conditions
    Store analyzer in protective pouch when not in use.
    Type
    Storage Environment Temperature
    Temperature Range
    36 – 46 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    18 – 28 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    64 – 82 Degrees Fahrenheit