MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST

MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST is an FDA 510(k)-cleared medical device (K861835) manufactured by Syva Co.. 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 28, 1986. Regulation: 8.