BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VITEK 2 YEAST CASPOFUNGIN

    Reg #: 1950204 · FEI: 1950204 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOMERIEUX, INC.
    Registration Number
    1950204
    FEI Number
    1950204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    595 ANGLUM RD.
    City
    HAZELWOOD
    State
    MO
    ZIP
    63042
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101566

    Owner / Operator

    Firm Name
    BIOMERIEUX SA
    Operator Number
    8020790
    Address
    Chemin De L Orme
    City
    Marcy L Etoile
    State
    Rhone
    Postal Code
    69280
    Country
    FR

    Products

    Device Name Product Code
    Susceptibility Test Plate, Antifungal NGZ
    Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems LRG

    Proprietary Names

    VITEK 2 YEAST CASPOFUNGIN

    Establishment Types

    Manufacture Medical Device