CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL is an FDA 510(k)-cleared medical device (K161928) 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 December 20, 2016. Regulation: 8.