BEUDAMED
    FDA Registration Active 🇺🇸 United States

    R40228 Gram Decolorizer,Enhanced

    Reg #: 1924669 · FEI: 1924669 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    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
    K791711

    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
    Iodine, Grams HYI

    Proprietary Names

    R40228 Gram Decolorizer,Enhanced R40235 Gram Iodine,Enhanced R40234 Gram Iodine,Enhanced R40225 Gram Crystal Violet,Enhanced R40231 Gram Enhancer R40240 Gram Stain Kit, Enhanced R40229 Gram Decolorizer,Enhanced R40238 Gram Safranin,Enhanced R40232 Gram Enhancer R40226 Gram Crystal Violet-Enhanced R40237 Gram Safranin,Enhanced Gram Safranin, Enhanced Gram Stain Kit, Enhanced Gram Crystal Violet, Enhanced Gram Iodine, Enhanced Gram Decolorizer, Enhanced Gram Enhancer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility