MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING

MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING is an FDA 510(k)-cleared medical device (K143483) 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 January 7, 2015. Regulation: 8.