BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Sensititre 18-24 hour MIC or BP Susceptibility System with Ceftobiprole 008-16 µg/mL

    Reg #: 8021914 · FEI: 3002806332 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TREK DIAGNOSTIC SYSTEMS, LTD.
    Registration Number
    8021914
    FEI Number
    3002806332
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Units 17 - 19, Birches Industrial Estate
    City
    East Grinstead West Sussex
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K243169

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    US Agent

    Business Name
    Remel Inc.
    Contact Name
    Alycia Jayroe
    Address
    12076 Santa Fe Trail
    City
    Lenexa
    State
    KS
    ZIP
    66215
    Country
    US
    Email
    [email protected]
    Phone
    913 9540078

    Products

    Device Name Product Code
    Panels, Test, Susceptibility, Antimicrobial LTT
    Manual Antimicrobial Susceptibility Test Systems JWY
    Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems LRG

    Proprietary Names

    Sensititre 18-24 hour MIC or BP Susceptibility System with Ceftobiprole 008-16 µg/mL

    Establishment Types

    Manufacture Medical Device