ORTHO CMV-M ANTIBODY ELISA TEST

ORTHO CMV-M ANTIBODY ELISA TEST is an FDA 510(k)-cleared medical device (K905077) manufactured by Ortho Diagnostic Systems, 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 December 16, 1990. Regulation: 8.