DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST

DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST is an FDA 510(k)-cleared medical device (K844407) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. 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 24, 1985. Regulation: 8.