BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAMBA II SARS-CoV-2/RSV Test

    Reg #: 3006247421 · FEI: 3006247421 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DIAGNOSTICS FOR THE REAL WORLD, LTD.
    Registration Number
    3006247421
    FEI Number
    3006247421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    220 Vineyard Ct Ste 150
    City
    Morgan Hill
    State
    CA
    ZIP
    95037
    Country
    US

    Owner / Operator

    Firm Name
    DIAGNOSTICS FOR THE REAL WORLD, LTD.
    Operator Number
    9100726
    Address
    220 Vineyard Court Ste 150
    City
    Morgan Hill
    State
    CA
    Postal Code
    95037
    Country
    US
    Correspondent
    Lourdes M Nadala

    Products

    Device Name Product Code
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF

    Proprietary Names

    SAMBA II SARS-CoV-2/RSV Test SAMBA II SARS-CoV-2/FluA/FluB Test

    Establishment Types

    Manufacture Device in the United States for Export Only