BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prosigna(R) Breast Cancer Prognostic Gene Signature Assay

    Reg #: 3007808978 · FEI: 3007808978 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Veracyte, Inc.
    Registration Number
    3007808978
    FEI Number
    3007808978
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6000 Shoreline Ct Ste 300
    City
    S San Fran
    State
    CA
    ZIP
    94080
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130010

    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
    Correspondent
    Peter Trinder

    Products

    Device Name Product Code
    Instrumentation For Clinical Multiplex Test Systems NSU
    Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer NYI

    Proprietary Names

    Prosigna(R) Breast Cancer Prognostic Gene Signature Assay

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198