BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HBA1cDx TQ, Gen.3, 500 Tests cobas c513

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    2

    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
    K160571

    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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hemoglobin A1c Test System PDJ

    Proprietary Names

    HBA1cDx TQ, Gen.3, 500 Tests cobas c513 cobas c 513 Analyzer Tina-quant Hemoglobin A1cDx Gen. 3 cobas c 513 software cobas c513 cobas c513 analyzer commercial system

    Establishment Types

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