BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KIT COBAS 4800 HXV CONTROLS 10T CE-IVD

    Reg #: 2028492 · FEI: 1000125183 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VENTANA MEDICAL SYSTEMS, INC.
    Registration Number
    2028492
    FEI Number
    1000125183
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1910 EAST INNOVATION PARK DR.
    City
    Tucson
    State
    AZ
    ZIP
    85755
    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
    General Purpose Reagent PPM

    Proprietary Names

    KIT COBAS 4800 HXV CONTROLS 10T CE-IVD KIT COBAS 6800/8800 HEV RMC CE-IVD KIT COBAS 6800/8800 DPX RMC CE-IVD KIT COBAS 4800 HCV GT CTLS 10T CE-IVD KIT COBAS 6800/8800 HEV 96T CE-IVD HybClear Solution-US EXPORT KIT COBAS 4800 LYSIS 2 240T CE-IVD KIT COBAS 6800/8800 DPX 96T CE-IVD KIT COBAS 4800 SAMPLE PREP 2 240T CE-IVD KIT COBAS 4800 SPEC DIL 2 240T CE-IVD KIT COBAS 58/68/8800 DPX RMC CE-IVD KIT COBAS 58/68/8800 HEV RMC CE-IVD KIT COBAS 4800 HCV 120T CE-IVD KIT COBAS 58/68/8800 DPX 192T CE-IVD KIT COBAS 58/68/8800 HEV 192T CD-IVD KIT C4800 HCV GT AMP/DET 120T CE-IVD

    Establishment Types

    Manufacture Device in the United States for Export Only