BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Roche Lumira Dx Bathgate

    Reg #: 3039322300 · FEI: 3039322300 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Roche Lumira Dx Bathgate
    Registration Number
    3039322300
    FEI Number
    3039322300
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    39 Inchmuir Road, Whitehill Industrial Estate
    City
    Bathgate Scotland
    Country
    GB

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    US Agent

    Business Name
    ROCHE DIAGNOSTICS OPERATIONS INC.
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 3194485

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP

    Proprietary Names

    LumiraDx SARS-CoV-2 Ag (48T)EUA ,EN-US LumiraDx Instrument V5E (EN,US) EUA LumiraDx SARS-CoV-2 Ag Quality Controls LumiraDx SARS-CoV-2 Ag Control (2pk)EUA LumiraDx SARS-CoV-2 Ag Test LMDx Instrument V5E (EN,US) EUA,Serviced

    Establishment Types

    Manufacture Medical Device