WELLCOLEX COLOUR SHIGELLA TEST ZC51

WELLCOLEX COLOUR SHIGELLA TEST ZC51 is an FDA 510(k)-cleared medical device (K895461) manufactured by Wellcome 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 January 10, 1990. Regulation: 8.