San Diego, CA, US · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QWB | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | Class II | Microbiology | 2 | 2023-11-28 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-05-24 | Class II | Ongoing | Z-0091-2025 | Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (O… | — | Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization. |