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    FDA Registration Active 🇺🇸 United States

    KT-826 Fecal Helicobacter Pylori Antigen ELISA Kit

    Reg #: 2032839 · FEI: 3004185580 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EPITOPE DIAGNOSTICS, INC.
    Registration Number
    2032839
    FEI Number
    3004185580
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7110 Carroll Rd
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Owner / Operator

    Firm Name
    EPITOPE DIAGNOSTICS, INC.
    Operator Number
    9059077
    Address
    7110 CARROLL RD, --
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    PING - GAO

    Products

    Device Name Product Code
    Helicobacter Pylori LYR

    Proprietary Names

    KT-826 Fecal Helicobacter Pylori Antigen ELISA Kit KT-1015 Helicobacter Pylori IgG ELISA Kit KT-824 Fecal H.pylori Antigen ELISA Kit KT-929 EpiTuub Fecal H. pylori Antigen Rapid Test Kit CL0826 Fecal Helicobacter pylori Antigen CLIA Kit KT-113 eCasset™ Helicobacter pylori Antigen Rapid Test Kit

    Establishment Types

    Manufacture Device in the United States for Export Only