BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KIT COBAS 6800/8800 CT/NG RMC IVD

    Reg #: 2243471 · FEI: 2243471 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

    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
    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

    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

    Manufacture Medical Device