Data / Medical devices / United States / Lumos Diagnostics, Inc.
Lumos Diagnostics, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 2 510(k) clearances
Lumos Diagnostics, Inc. is registered with the FDA (registration 3006602209) in Carlsbad, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006602209
- Address
- 2724 Loker Ave W, Carlsbad, CA, United States, 92010
- Owner or operator
- Lumos Diagnostics, Inc. (9075965)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- July 20, 2023
- Registered through
- 2026
- Brand names listed
- FebriDx Bacterial / Non-Bacterial Assay, FebriDx Bacterial / Non-bacterial Point of Care Assay, FebriDx External Controls, FebriDx Test, INDICAID FebriDx Bacterial / Non-Bacterial Assay
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection | QXA | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2026 | K260787 | FebriDx Bacterial/Non-bacterial Assay | QXA | Substantially Equivalent | Lumos Diagnostics, Inc. | accessdata.fda.gov |
| June 30, 2023 | K230917 | FebriDx Bacterial / Non-bacterial Point of Care Assay | QXA | Substantially Equivalent | Lumos Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.