FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES

FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES is an FDA 510(k)-cleared medical device (K863798) manufactured by Whittaker Bioproducts, 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 April 13, 1987. Regulation: 8.