Chembio Diagnostics, Inc

FDA Regulatory Profile

Chembio Diagnostics, Inc appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2809-2020, Class II) was initiated on June 18, 2020.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2809-2020Class IIChembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatograpJune 18, 2020
Z-2807-2020Class IIChembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detectionJune 18, 2020
Z-2808-2020Class IIChembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographicJune 18, 2020