VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM

VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM is an FDA 510(k)-cleared medical device (K890610) manufactured by Organon Teknika Corp.. 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 22, 1989. Regulation: 8.