BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Serim® PyloriTek® Test Kit

    DI: M1745140K1 · Model: 05140K · SERIM RESEARCH CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    20

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    Basic Information

    Brand Name
    Serim® PyloriTek® Test Kit
    Primary DI
    M1745140K1
    Version / Model
    05140K
    Catalog Number
    05140K
    Company Name
    SERIM RESEARCH CORPORATION
    Labeler DUNS
    605151018
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    5
    Public Version Date
    2026-02-09
    Public Version Status
    Update
    Public Device Record Key
    b3f89921-9db5-4b95-bfa5-a0baba6fd881

    Device Description

    The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    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
    LYR Helicobacter Pylori

    GMDN Terms

    Code Name
    52787 Helicobacter pylori urease IVD, kit, chromogenic

    Identifiers

    Type ID
    Package M1745140K2
    Primary M1745140K1
    Unit of Use M1745140K0
    Package M1745140D2

    Customer Contacts

    Phone
    800-542-4670
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K953632 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 7 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius