BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ariosa DANSR Library Rgt Kit Box 1 CE-IVD

    Reg #: 3009731198 · FEI: 3009731198 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Roche Diagnostics Santa Clara
    Registration Number
    3009731198
    FEI Number
    3009731198
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2881 Scott Blvd.
    City
    Santa Clara
    State
    CA
    ZIP
    95050
    Country
    US

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    Products

    Device Name Product Code
    System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection PFX

    Proprietary Names

    Ariosa DANSR Library Rgt Kit Box 1 CE-IVD Ariosa DANSR Library Rgt Kit Box 2 CE-IVD Ariosa DANSR Detect Rgt Kit Box 4 CE-IVD Ariosa DANSR Detect Rgt Kit Box 1 CE-IVD Ariosa DANSR Detect Rgt Kit Box 3 CE-IVD DANSR Library Box 1B IVD

    Establishment Types

    Manufacture Device in the United States for Export Only