CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY

CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY is an FDA 510(k)-cleared medical device (K935809) manufactured by Light Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 4, 1994. Regulation: 8.