BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KIT COBAS LIAT SARS-COV-2/FLU

    Reg #: 3004141078 · FEI: 3004141078 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    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

    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
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR

    Proprietary Names

    KIT COBAS LIAT SARS-COV-2/FLU cobas® SARS-CoV-2 & Influenza A/B Control Kit KIT COBAS LIAT SARS-COV-2/FLU CTL cobas® SARS-CoV-2 & Influenza A/B for use on the cobas® 6800/8800 Systems KIT COBAS 6800/8800 SARS-COV-2 192T KIT COBAS 6800/8800 SARS-COV-2 RMC KIT COBAS 6800/8800 SARS-COV-2/FLU RMC cobas® SARS-CoV-2 - 480T KIT COBAS 6800/8800 SARS-COV-2/FLU 384T cobas® SARS-CoV-2 Quality Control Kit KIT COBAS 6800/8800 SARS-COV-2 480T KIT C68/88 SARS-COV2 DUO 192T KIT C68/88 SARS-COV2 DUO RMC KIT COBAS 58/68/8800 SARSCOV2FLUV2 192T KIT COBAS 58/68/8800 SARS-COV-2/FLU RMC SARS-CoV-2 Ag Test

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility