BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    cobas 4800 system

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    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

    Regulatory Submissions

    510(k) Number
    K142721

    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
    Real Time Nucleic Acid Amplification System OOI
    System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen NQX

    Proprietary Names

    cobas 4800 system cobas MRSA/SA Test cobas 4800 MRSA/SA Controls and Cofactor Kit, 10 Runs SW C4800 2.1 MRSA/SA AP V1.1 CD KIT COBAS4800 MIXEDBATCH LYSIS1 960T IVD KIT COBAS 4800 MRSA/SA AMP/DET240T IVD KIT COBAS4800 MIXEDBATCH LYSIS1 240T IVD KIT COBAS 4800 MIXEDBATCH INT CTRL 1 IVD cobas 4800 MRSA/SA Amplification/Detection Kit, 240 Tests cobas 4800 MRSA/SA Amplification/Detection Kit, 80 Test KIT COBAS 4800 MRSA/SA CONTROLS IVD KIT COBAS 4800 MRSA/SA AMP/DET 80T IVD

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device