BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lumos Diagnostics, Inc.

    Reg #: 3006602209 · FEI: 3006602209 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Lumos Diagnostics, Inc.
    Registration Number
    3006602209
    FEI Number
    3006602209
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2724 Loker Avenue
    City
    Carlsbad
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230917

    Owner / Operator

    Firm Name
    Lumos Diagnostics, Inc.
    Operator Number
    9075965
    Address
    2724 Loker Ave W
    City
    Carlsbad
    State
    CA
    Postal Code
    92010
    Country
    US

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection QXA

    Proprietary Names

    FebriDx External Controls FebriDx Test FebriDx Bacterial / Non-bacterial Point of Care Assay INDICAID FebriDx Bacterial / Non-Bacterial Assay FebriDx Bacterial / Non-Bacterial Assay

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only