BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    cobas b 123 FLUID PACK 700

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    13

    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
    K111188

    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
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Oxyhemoglobin GGZ
    Whole Blood Hemoglobin Determination KHG
    Oximeter To Measure Hemoglobin GLY
    Acid, Lactic, Enzymatic Method KHP
    Glucose Oxidase, Glucose CGA
    Assay, Carboxyhemoglobin GHS
    Electrode, Ion Specific, Calcium JFP
    Abnormal Hemoglobin Quantitation GKA
    Instrument, Hematocrit, Automated GKF
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Sodium JGS
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL

    Proprietary Names

    cobas b 123 FLUID PACK 700 cobas b 123 FLUID PACK COOX 400 cobas b 123 FLUID PACK COOX 700 cobas b 123 FLUID PACK 200 cobas b 123 SENSOR CART. BG/ISE/GLU/LAC cobas b 123 FLUID PACK 400 TESTS

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device