BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MagNA Pure 24 Piercing Tool

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    58
    Establishment Types
    3
    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
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG

    Proprietary Names

    MagNA Pure 24 Piercing Tool LIGHTCYCLER CLASSIC ROTOR UPGRADE KIT CLOT CATCHER [250 PC] MPLC CB, Reaction Tubes MagNa Pure RXN TIPS-LARGE MagNa Pure REAGENT TUB LID (Large) MP Compact Waste Tank MPLC CB, 96-well PCR Plate PC/CC-CUPS cobas p 680 START-UP KIT MagNA Pure 24 Tip Park/Piercing Tool Lightcycler 2 Centrifuge AVENIO MILLISECT System MagNa Pure Compact Tube Rack MagNa Pure Waste accessories Lightcycler O-Ring Clot Catcher Pro [100 PCS] MagNa Pure Lyser Rotor MagNa Lyser 115V MagNa Pure Compact Elution Tube Rack MagNa Pure Compact Drop catcher Lightcycler Color Compensation Set MagNa Pure Liquid Waste Funnel MagNa Pure Compact Cartridge Rack MagNa Pure LC 2 Instrument MagNa Pure Compact Drip Tray MPLC O-Ring Maintenance Kit MPLC Greasing Set MagNa Pure 96 Purification Rack IVD MagNa Pure LC Cool Block, Sample Carousel Cell Set cobas C311 SW cobas omni UCT 3.1 REFERENCE ELECTRODE ISE 91XX MPLC Reagent Tub (SMALL) MPLC Reaction Tip (small) MPLC Tub Lid (Large) MagNa Pure 96 Reagent Rack IVD MPLC TUB LID SEAL MPLC TUB LID (Small, Medium) ISD Sample PT Elecsys cobas e 100 Instrument Check MagNa Pure 96 Waste Rack IVD Avenio Millisect System 2 MagNa Pure 96 Output Plate CONA, 100Tests, cobas c503 Carry-over Needle Assessment MICRO ELECTRODE REF cobas Omni Processing Plate cobas Omni Pipette Tips MagNa Pure 96 Processing Cartridge cobas Omni Amplification Plate MagNa Pure 96 Processing Plate AssayTip/AssayCup tray LIGHTCYCLER ACCESSORIES ControlSet Vials Elecsys,cobas e CalSet Vials Elecsys,cobas e MagNA Pure 96 Dropcatcher IVD MAGNAPURE ACCESSORIES

    Establishment Types

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