BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    cobas® EZH2 Mutation Test

    Reg #: 3003795116 · FEI: 3003795116 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROCHE DIAGNOSTICS INTERNATIONAL LTD.
    Registration Number
    3003795116
    FEI Number
    3003795116
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    FORRENSTRASSE 2
    City
    ROTKREUZ Zug
    Country
    CH

    Regulatory Submissions

    PMA Number
    P200014

    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 5214603

    Products

    Device Name Product Code
    Somatic Gene Mutation Detection System OWD

    Proprietary Names

    cobas® EZH2 Mutation Test SW C4800 EZH2 AP V1 CD KIT COBAS 4800 EZH2 AMP/DET 24T IVD cobas® EZH2 Analysis Package Software version 1

    Establishment Types

    Manufacture Medical Device