BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prosigna(R) Breast Cancer Prognostic Gene Signature Assay

    Reg #: 3006389928 · FEI: 3006389928 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NanoString, a Bruker Company
    Registration Number
    3006389928
    FEI Number
    3006389928
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3350 Monte Villa Pkwy
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130010

    Owner / Operator

    Firm Name
    NanoString, a Bruker Company
    Operator Number
    10042333
    Address
    3350 Monte Villa Parkway
    City
    Bothell
    State
    WA
    Postal Code
    98021
    Country
    US
    Correspondent
    Sree Sowmya Tumuluru

    Products

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

    Proprietary Names

    Prosigna(R) Breast Cancer Prognostic Gene Signature Assay

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)