IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530

IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 is an FDA 510(k)-cleared medical device (K872942) manufactured by Clinical Sciences, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 1988. Regulation: 8.