BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MagNA Pure 96 DNA and Viral NA Large Volume Kit

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ROCHE DIAGNOSTICS GMBH
    Registration Number
    9610126
    FEI Number
    3002806559
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SANDHOFER STRASSE 116
    City
    MANNHEIM Baden-Wurttemberg
    Country
    DE

    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
    Clinical Sample Concentrator JJH

    Proprietary Names

    MagNA Pure 96 DNA and Viral NA Large Volume Kit cobas x480 Instrument MagNA Pure LC Instrument MagNA Pure 24 Instrument MagNa Pure 96 Bottle Rack IVD MagNA Pure 96 Bacterial Lysis Buffer IVD MagNA Pure 96 SW v3.1 MagNA Pure 96 System Software Version 3.1.1 MagNA Pure 96 DNA and Viral NA SV Kit IVD MagNa Pure 96 Reagent Loop Unit IVD MagNA Pure 96 DNA Tissue Lysis Buffer MagNA Pure 96 Protocol Set 1 MagNA Pure 96 Bacterial Lysis Buffer MagNA Pure 96 Plate Holder IVD MagNA Pure 96 External Lysis Buffer MagNA Pure 24 Protocol Set 1 MagNA Pure 24 Protocol Set v1.3 MagNA Pure 24 Protocol Set MagNA Pure 24 Protocols v1.4 MagNA Pure FFPET Buffer Set MagNA Pure 24 SW 1.1 FFPET Isolation Kit MagNA Pure 96 Instrument

    Establishment Types

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