BEUDAMED
    FDA Registration Active 🇫🇷 France

    NG-Test CARBA 5

    Reg #: 3012516784 · FEI: 3012516784 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NG BIOTECH
    Registration Number
    3012516784
    FEI Number
    3012516784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZA Courbouton Secteur 1
    City
    GUIPRY Bretagne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K191889

    Owner / Operator

    Firm Name
    NG BIOTECH
    Operator Number
    10061777
    Address
    ZA Courbouton Secteur 1
    City
    GUIPRY
    State
    Bretagne
    Postal Code
    35480
    Country
    FR
    Correspondent
    Jean Baptiste BAUDIER

    US Agent

    Business Name
    Hardy Diagnostics
    Contact Name
    Ashleigh Rickey
    Address
    429 S Pioneer Boulevard
    City
    Springboro
    State
    OH
    ZIP
    45066
    Country
    US
    Email
    [email protected]
    Phone
    805 3462766 ext. 7045

    Products

    Device Name Product Code
    Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates PTJ

    Proprietary Names

    NG-Test CARBA 5

    Establishment Types

    Manufacture Medical Device