Chembio Diagnostics, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2807-2020 | Class II | Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection | June 18, 2020 |
| Z-2808-2020 | Class II | Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic | June 18, 2020 |
| Z-2809-2020 | Class II | Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatograp | June 18, 2020 |