DIAMEDIX IS-CMV IGG TEST SYSTEM

DIAMEDIX IS-CMV IGG TEST SYSTEM is an FDA 510(k)-cleared medical device (K981163) manufactured by Diamedix 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 September 20, 1998. Regulation: 8.