BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENEXPERT DX SYSTEM

    Reg #: 3007867838 · FEI: 1000161215 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sanmina
    Registration Number
    3007867838
    FEI Number
    1000161215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2700 N 1st St
    City
    SAN JOSE
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060540

    Owner / Operator

    Firm Name
    Sanmina Corporation
    Operator Number
    2129538
    Address
    13000 S. Memorial Pkwy, --
    City
    Huntsville
    State
    AL
    Postal Code
    35803
    Country
    US

    Products

    Device Name Product Code
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR

    Proprietary Names

    GENEXPERT DX SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)