BEUDAMED
    FDA Registration Active 🇺🇸 United States

    cobas 4800 system

    Reg #: 2243471 · FEI: 2243471 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ROCHE MOLECULAR SYSTEMS, INC.
    Registration Number
    2243471
    FEI Number
    2243471
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1080 US Highway 202 South
    City
    Branchburg
    State
    NJ
    ZIP
    08876
    Country
    US

    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

    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

    Manufacture Medical Device