BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    cobas INTEGRA ISE SOLUTION 2

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    5

    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
    K963627

    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
    Calibrator, Multi-Analyte Mixture JIX
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ

    Proprietary Names

    cobas INTEGRA ISE SOLUTION 2 COBAS INTEGRA ISE SOL.1. 6 x 17,5 ML ISE Standard low 10x3ML ISE CALIBRATOR INDIRECT (250 ML) cobas INTEGRA ISE CAL DIRECT 250 ML H ISE STD LOW 10X3ML ELECTRODE ISE SODIUM ISE Standard high 10x3ML ELECTRODE REFERENCE ISE (0980) ELECTRODE ISE POTASSIUM cobas INTEGRA ISE CAL INDIRECT 250 ML COBAS INTEGRA ISE SOLUTION 3. 6 x 9,5ML ISE CALIBRATOR DIRECT (250 ML) H ISE STD HIGH 10X3ML COBAS INTEGRA ISE SOLUTION 2. 6 x 9,5 ML Electrode Chloride Cl/ISE (0980) Integra Ion Selective Electrode (ISE) Module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device