FDA-Device2020-08-26Class II
Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1070-0
Chembio Diagnostics, Inc
Hazard
FDA revocation of the Emergency Use Authorization due to performance issues
Sold states
Nationwide
Affected count
97 kits
Manufactured in
3661 Horseblock Rd, N/A, Medford, NY, United States
Products
Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1070-0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2809-2020Don't want to check this manually?
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