BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xpert HCV

    Reg #: 3004530258 · FEI: 3004530258 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CEPHEID
    Registration Number
    3004530258
    FEI Number
    3004530258
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    904 CARIBBEAN DRIVE
    City
    Sunnyvale
    State
    CA
    ZIP
    94089
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240016

    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
    Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test SBP

    Proprietary Names

    Xpert HCV

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility