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    FDA Registration Active 🇺🇸 United States

    CL0824 Fecal Clostridium Difficile GDH Antigen CLIA Kit

    Reg #: 2032839 · FEI: 3004185580 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    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
    Reagents, Clostridium Difficile Toxin LLH

    Proprietary Names

    CL0824 Fecal Clostridium Difficile GDH Antigen CLIA Kit KT-828 Fecal C. difficile GDH ELISA Kit KT-935 EpiTuub® Fecal C. difficile Antigen Test Kit KT-834 Fecal C.difficile Toxin A ELISA Kit CL0836 Fecal Clostridium Difficile Toxin A & B CLIA Kit KT-836 Fecal C.difficile Toxin A & B ELISA Kit CL0827 Fecal Clostridium Difficile Toxin A CLIA Kit CL0828 Fecal Clostridium Difficile Toxin B CLIA Kit KT-835 Fecal C.difficile Toxin B ELISA Kit

    Establishment Types

    Manufacture Medical Device