CAPI 3 Immunotyping, Capillarys 3 Tera

CAPI 3 Immunotyping, Capillarys 3 Tera is an FDA 510(k)-cleared medical device (K192095) manufactured by Sebia. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 2019. Regulation: 8.