Panels › Microbiology › Product code QXA · Class 2
Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
Regulation 866.3230
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QXA
| Company | 510(k)s | Recalls |
|---|---|---|
| Lumos Diagnostics, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 24, 2026 | K260787 | FebriDx Bacterial/Non-bacterial Assay Lumos Diagnostics, Inc. | QXA |
| Jun 30, 2023 | K230917 | FebriDx Bacterial / Non-bacterial Point of Care Assay Lumos Diagnostics, Inc. | QXA |
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