BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INFLAMMATIX

    Reg #: 3022977716 · FEI: 3022977716 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INFLAMMATIX
    Registration Number
    3022977716
    FEI Number
    3022977716
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    540 Oakmead Pkwy
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241676

    Owner / Operator

    Firm Name
    Inflammatix (1 650-443-3030)
    Operator Number
    10092481
    Address
    540 Oakmead Pkwy
    City
    Sunnyvale
    State
    CA
    Postal Code
    94085
    Country
    US
    Correspondent
    Diana J Lane

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI
    Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers PRE
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    TriVerity Myrna TriVerity Quality Control Level 1 TriVerity Quality Control Level 2 TriVerity Mini Verification Panel TriVerity Verification Panel

    Establishment Types

    Manufacture Medical Device