BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xpert BCR-ABL Ultra

    Reg #: 3016838963 · FEI: 3016838963 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Cepheid
    Registration Number
    3016838963
    FEI Number
    3016838963
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    121 N Guild Ave
    City
    Lodi
    State
    CA
    ZIP
    95240
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190076

    Owner / Operator

    Firm Name
    CEPHEID
    Operator Number
    9062742
    Address
    904 CARIBBEAN DRIVE, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94089
    Country
    US
    Correspondent
    Somesh Lalithraj

    Products

    Device Name Product Code
    Bcr/Abl1 Monitoring Test OYX
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    Xpert BCR-ABL Ultra

    Establishment Types

    Manufacture Medical Device