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    FDA Registration Active 🇺🇸 United States

    CL0850 Quantitative Fecal Occult Blood (q-FOB) CLIA Kit

    Reg #: 2032839 · FEI: 3004185580 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    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

    Regulatory Submissions

    510(k) Number
    K051806

    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
    Reagent, Occult Blood KHE

    Proprietary Names

    CL0850 Quantitative Fecal Occult Blood (q-FOB) CLIA Kit KT-313 EpiTuub FOB Rapid Test Kit KT-111 FOB Rapid Test Kit KT-850 q-FOB Quantitative Fecal Occult Blood Test Kit

    Establishment Types

    Manufacture Medical Device