ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)

ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) is an FDA 510(k)-cleared medical device (K954301) manufactured by Abbott Laboratories. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 1997. Regulation: 8.