BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fungitell (cleared as Glucatell)

    Reg #: 1219145 · FEI: 1219145 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASSOCIATES OF CAPE COD, INC.
    Registration Number
    1219145
    FEI Number
    1219145
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    124 Bernard E. Saint Jean Drive
    City
    E Falmouth
    State
    MA
    ZIP
    02536
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN040003

    Owner / Operator

    Firm Name
    ASSOCIATES OF CAPE COD, INC.
    Operator Number
    1219145
    Address
    124 Bernard E. Saint Jean Drive
    City
    East Falmouth
    State
    MA
    Postal Code
    02536
    Country
    US
    Correspondent
    Debbie - Fraser

    Products

    Device Name Product Code
    Antigen, Invasive Fungal Pathogens NQZ

    Proprietary Names

    Fungitell (cleared as Glucatell) FUNGITELL (CLEARED UND

    Establishment Types

    Manufacture Medical Device