BEUDAMED
    FDA Registration Active 🇺🇸 United States

    cobas® EBV/BKV Control Kit

    Reg #: 3004141078 · FEI: 3004141078 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROCHE MOLECULAR SYSTEMS, INC.
    Registration Number
    3004141078
    FEI Number
    3004141078
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4300 HACIENDA DRIVE
    City
    PLEASANTON
    State
    CA
    ZIP
    94588
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202215

    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
    Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna QMI

    Proprietary Names

    cobas® EBV/BKV Control Kit cobas® BKV KIT COBAS 6800/8800 BKV 192T IVD KIT COBAS 6800/8800 EBV/BKV RMC IVD cobas® BKV for use on cobas® 6800/8800 Systems

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility