DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader is an FDA 510(k)-cleared medical device (K200506) manufactured by Chembio Diagnostic Systems. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2020. Regulation: 8.