BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SeptiCyte RAPID

    Reg #: 3016504919 · FEI: 3016504919 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMMUNEXPRESS, INC
    Registration Number
    3016504919
    FEI Number
    3016504919
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    425 Pontius Avenue North, Suite 470
    City
    Seattle
    State
    WA
    ZIP
    98109
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232095

    Owner / Operator

    Firm Name
    Immunexpress, Inc
    Operator Number
    10083917
    Address
    425 Pontius Avenue North, Suite 470
    City
    Seattle
    State
    WA
    Postal Code
    98109
    Country
    US
    Correspondent
    LaKesha Hunt

    Products

    Device Name Product Code
    Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers PRE

    Proprietary Names

    SeptiCyte RAPID

    Establishment Types

    Manufacture Medical Device