BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Xpert Xpress Flu/RSV

    Reg #: 3009613136 · FEI: 3009613136 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CEPHEID AB
    Registration Number
    3009613136
    FEI Number
    3009613136
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rontgenvagen 5
    City
    SOLNA Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K162331

    Owner / Operator

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

    US Agent

    Business Name
    CEPHEID
    Contact Name
    Somesh Lalithraj
    Address
    904 E Caribbean Dr
    City
    Sunnyvale
    State
    CA
    ZIP
    94089
    Country
    US
    Email
    [email protected]
    Phone
    408 2427416

    Products

    Device Name Product Code
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Culture Media, Non-Propagating Transport JSM

    Proprietary Names

    Xpert Xpress Flu/RSV

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)