BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Total PSA Elecsys cobas e 100

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    20
    Establishment Types
    1
    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

    PMA Number
    P990056

    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
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer MTF

    Proprietary Names

    Total PSA Elecsys cobas e 100 Elecsys total PSA cobas e-ELECSYS PSA [200] Total PSA G2 CS Elecsys Total PSA ELECSYS TOTAL PSA Elecsys total PSA - 100 test kit Elecsys total PSA - 200 test kit Total PSA G2 CS Elecsys V2.1 Total PSA CalSet II total PSA Ca1Set II Total PSA Elecsys E2G 300 Total PSA Elecsys cobas e 200 V2 total PSA Gen.2.1 Elecsys,cobas e Total PSA Elecsys E2G 300 V2 Total PSA Elecsys cobas e 100 V3 Total PSA G2 CS Elecsys V3 total PSA CalSet II Total PSA Elecsys E2G 100 V2 Elecsys total PSA Test System

    Establishment Types

    Manufacture Medical Device