VZVSCAN(TM) LATEX AGGUTINATION TEST

VZVSCAN(TM) LATEX AGGUTINATION TEST is an FDA 510(k)-cleared medical device (K912239) 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 June 10, 1991. Regulation: 8.