BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Streptococcal Grouping Kit

    Reg #: 3003750284 · FEI: 3003750284 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    1

    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

    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
    Antisera, All Groups, Streptococcus Spp. GTZ

    Proprietary Names

    Streptococcal Grouping Kit Polyvalent Positive Control Extraction Enzyme Streptococcal Grouping Reagent C DR0707G PathoDxtra Polyvalent Positive Control DR0704G PATHODXTRA STREP GROUP D LATEX DR0702G PATHODXTRA STREP GROUP B LATEX DR0709M PathoDxtra Extraction Reagents DR0589G Latex Grouping Reagent D DR0700M PathoDxtra Strep Grouping Kit (60 tests) DR0587G Latex Grouping Reagent B DR0710M PATHODXTRA STREP GROUPING REAGENT SET Streptococcal Grouping Reagent A Streptococcal Grouping Reagent F DR0705G PATHODXTRA STREP GROUP F LATEX Streptococcal Grouping Reagent D Streptococcal Grouping Reagent B DR0590G Latex Grouping Reagent F DR0591G Latex Grouping Reagent G DR0500G Oxoid Reaction Cards Strep Plus Extraction Reagent Kit DR0703G PATHODXTRA STREP GROUP C LATEX DR0701G PATHODXTRA STREP GROUP A LATEX DR0586G Latex Grouping Reagent A DR0588G Latex Grouping Reagent C DR0720G PATHODXTRA DISPOSABLE CARDS DrySpot Pneumo Streptococcal Grouping Reagent G Strep Plus Kit DR0706G PATHODXTRA STREP GROUP G LATEX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)