BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    PathoDX Adenovirus Reagent

    Reg #: 3003750284 · FEI: 3003750284 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    REMEL EUROPE LTD
    Registration Number
    3003750284
    FEI Number
    3003750284
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    REMEL HOUSE, CLIPPER BLVD., WEST CROSSWAYS
    City
    DARTFORD, KENT
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K983336

    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 8954063

    Products

    Device Name Product Code
    Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 GQS
    Antigens, Cf (Including Cf Control), Influenza Virus A, B, C GNX
    Respiratory Syncytial Virus, Antigen, Antibody, Ifa LKT
    Antisera, Fluorescent, Adenovirus 1-33 GNY

    Proprietary Names

    PathoDX Adenovirus Reagent PathoDX RSV Screening Reagent PathoDX Influenza A Reagent PathoDX Respiratory Mounting Fluid PathoDX RVP Negative Control Reagent PathoDX Parainfluenza 2 Reagent PathoDX RVP Control PathoDX Influenza B Reagent PathoDX RVP Screen Reagent PathoDX Respiratory Viral Panel PathoDX Parainfluenza 1 Reagent PathoDX Parainfluenza 3 Reagent

    Establishment Types

    Manufacture Medical Device