BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Guardant360 CDx

    Reg #: 3012090384 · FEI: 3012090384 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GUARDANT HEALTH, INC (Campus)
    Registration Number
    3012090384
    FEI Number
    3012090384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    505 Penobscot Dr
    City
    Redwood City
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    PMA Number
    P200010

    Owner / Operator

    Firm Name
    Guardant Health, Inc
    Operator Number
    10078033
    Address
    505 Penobscot Dr
    City
    Redwood City
    State
    CA
    Postal Code
    94063
    Country
    US
    Correspondent
    Nameeta Mujumdar

    Products

    Device Name Product Code
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System PQP

    Proprietary Names

    Guardant360 CDx

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198