BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    KIT COBAS 6800/8800 CT/NG RMC IVD

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

    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
    K173887

    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
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    Dna-Reagents, Neisseria LSL
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    KIT COBAS 6800/8800 CT/NG RMC IVD KIT COBAS 6800/8800 CT/NG 480T IVD SW cobas CT/NG ASAP 11.1 SW cobas NG ASAP 11.1 SW COBAS 6800/8800 0138.1011 SW cobas CT ASAP 11.1 cobas® CT/NG for use on cobas® 6800/8800 systems cobas® CT/NG Positive Control Kit KIT COBAS 58/68/8800 CT/NG 480T IVD KIT COBAS 58/68/8800 CT/NG RMC IVD cobas® PCR Media Dual Swab Sample Kit cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® PCR Media Uni Swab Sample Kit cobas® PCR Urine Sample Kit

    Establishment Types

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