OPUS(R) ANTI CMV-M

OPUS(R) ANTI CMV-M is an FDA 510(k)-cleared medical device (K913080) manufactured by Pb 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 27, 1991. Regulation: 8.