BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    R2456096 ProSpecT Entamoeba histolytica Microplate Assay 96 Tests

    Reg #: 8010096 · FEI: 3006224287 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OXOID, LTD.
    Registration Number
    8010096
    FEI Number
    3006224287
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WADE RD.
    City
    BASINGSTOKE, HAMPSHIRE
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K933997

    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
    Antisera, Latex Agglutination, Cryptococcus Neoformans GMD

    Proprietary Names

    R2456096 ProSpecT Entamoeba histolytica Microplate Assay 96 Tests Prospect E. Histolytica

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility