BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R07128 MH Broth w/Cations

    Reg #: 1924669 · FEI: 1924669 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    REMEL, INC.
    Registration Number
    1924669
    FEI Number
    1924669
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12076 Santa Fe Trail Dr
    City
    LENEXA
    State
    KS
    ZIP
    66215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K850291

    Owner / Operator

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

    Products

    Device Name Product Code
    Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth JTZ

    Proprietary Names

    R07128 MH Broth w/Cations R01626 MH Agar w/4% NaCl,6ug Oxacillin R09598 MH Broth w/Cations R01622 MH Agar w/5% Sheep Blood R061470 MH Broth R04055 MH Agar w/5% Sheep Blood R04052 MH Agar R04050 MH Agar R061478 MH Broth R061472 MH Broth R01624 MH Agar R04057 MH Agar w/5% Sheep Blood R01620 MH Agar (100mm) 10/PK R09592 MH Agar (25ml deep) MH Agar w/4% NaCl,6ug Oxacillin

    Establishment Types

    Manufacture Medical Device