BEUDAMED
    FDA Registration Active 🇫🇷 France

    Prosigna(R) Breast Cancer Prognostic Gene Signature Assay

    Reg #: 3021140017 · FEI: 3021140017 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VERACYTE SAS
    Registration Number
    3021140017
    FEI Number
    3021140017
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Luminy Biotech Entreprises, 163 Avenue de Luminy
    City
    Marseille Provence-Alpes-Cote d'Azur
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K141771

    Owner / Operator

    Firm Name
    Veracyte, Inc.
    Operator Number
    10035252
    Address
    6000 Shoreline Court, Suite 300
    City
    South San Francisco
    State
    CA
    Postal Code
    94080
    Country
    US

    US Agent

    Business Name
    VERACYTE, INC.
    Contact Name
    Melissa Soriano
    Address
    6000 Shoreline Court, Suite 300
    City
    South San Francisco
    State
    CA
    ZIP
    94080
    Country
    US
    Email
    [email protected]
    Phone
    650 2436300

    Products

    Device Name Product Code
    Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer NYI

    Proprietary Names

    Prosigna(R) Breast Cancer Prognostic Gene Signature Assay

    Establishment Types

    Manufacture Medical Device