BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CalSet IGF-1

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    1

    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

    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, Secondary JIT

    Proprietary Names

    CalSet IGF-1 IGF-1 CS Elecsys IGFBP-3 CS Elecsys Androstenedione CS Elecsys CalSet IGFBP-3 CalSet Androstenedione Anti-TSHR CS Elecsys V2 TSH CS Elecsys TSH CalSet Vitamin D total G3 CS Elecsys FSH CS Elecsys V3 Testosterone II CalSet II CalSet Anti-TSHR proBNP STAT CS Elecsys V2.1 Troponin T Gen5 CS Elecsys E2G FSH CalSet II CalSet Vitamin D total III proBNP G2 CS Elecsys E2G V2.1 Elecsys Troponin T Gen 5 CalSet CalSet Phospho-Tau (181P) AFP G2 CS Elecsys V3 proBNP G2 CS Elecsys V2.1 Elecsys proBNP II STAT CalSet Elecsys proBNP II CalSet AMH CS Elecsys V2 LH G2 CS Elecsys V2 pTau CS Elecsys CalSet Total-Tau CalSet ?-Amyloid (1-42) II beta-Amyloid(1-42) G2 CS Elecsys sFLT1 CS Elecsys AFP CalSet II TG G2 CS Elecsys V2 Preciset LPA Gen.2, 5x1 ml ISE Internal Standard Gen.2 conc. PLGF CS Elecsys FSH CS Elecsys V3.1 tTau CS Elecsys

    Establishment Types

    Manufacture Medical Device