BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Agendia Inc

    Reg #: 3007297853 · FEI: 3007297853 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Agendia Inc
    Registration Number
    3007297853
    FEI Number
    3007297853
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22 Morgan
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141142

    Owner / Operator

    Firm Name
    AGENDIA Inc.
    Operator Number
    9101719
    Address
    Agendia Inc., 22 Morgan
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Melissa Chavis

    Products

    Device Name Product Code
    Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer NYI
    Container, Specimen Mailer And Storage, Non-Sterile NNK

    Proprietary Names

    MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit MammaPrint® FFPE Agendia Specimen Collection Kit

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device