BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Simplexa™ GBS Direct

    Reg #: 2023365 · FEI: 2023365 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DiaSorin Molecular LLC
    Registration Number
    2023365
    FEI Number
    2023365
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11331 Valley View St
    City
    CYPRESS
    State
    CA
    ZIP
    90630
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182467

    Owner / Operator

    Firm Name
    DiaSorin Molecular LLC
    Operator Number
    9089763
    Address
    11331 Valley View Street, --
    City
    Cypress
    State
    CA
    Postal Code
    90630
    Country
    US
    Correspondent
    Mari Meyer

    Products

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

    Proprietary Names

    Simplexa™ GBS Direct Simplexa™ GBS Positive Control Pack

    Establishment Types

    Manufacture Medical Device