ACCURUN 146 CMV IGM POSITIVE CONTROL

ACCURUN 146 CMV IGM POSITIVE CONTROL is an FDA 510(k)-cleared medical device (K972884) manufactured by Boston Biomedica, 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 August 21, 1997. Regulation: 8.