ENZY-WELL SYPHILIS IGG, MODEL 91106

ENZY-WELL SYPHILIS IGG, MODEL 91106 is an FDA 510(k)-cleared medical device (K050590) manufactured by Diesse Diagnostica Senese S.P.A.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 2006. Regulation: 8.