BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Alinity c Amikacin Reagent Kit

    Reg #: 3003561301 · FEI: 3003561301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    B.R.A.H.M.S GmbH
    Registration Number
    3003561301
    FEI Number
    3003561301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NEUENDORFSTRASSE 25
    City
    HENNIGSDORF Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K052815

    Owner / Operator

    Firm Name
    B.R.A.H.M.S GmbH
    Operator Number
    9051947
    Address
    NEUENDORFSTRASSE 25, --
    City
    HENNIGSDORF
    State
    Brandenburg
    Postal Code
    16761
    Country
    DE
    Correspondent
    Elli - Neu

    US Agent

    Business Name
    Fisher Diagnostics, as part of Thermo Fisher Scientific
    Contact Name
    Colleen Watson
    Address
    8365 Valley Pike
    City
    Middletown
    State
    VA
    ZIP
    22645
    Country
    US
    Email
    [email protected]
    Phone
    224 2797203

    Products

    Device Name Product Code
    Radioimmunoassay, Amikacin KLQ

    Proprietary Names

    Alinity c Amikacin Reagent Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility