DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM

DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM is an FDA 510(k)-cleared medical device (K001875) 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 August 20, 2000. Regulation: 8.