OPUS CMV TEST SYSTEM-MODIFICATION

OPUS CMV TEST SYSTEM-MODIFICATION is an FDA 510(k)-cleared medical device (K963084) manufactured by Behring Diagnostics, 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 October 8, 1996. Regulation: 8.