MACRO-VUE RUBELLA CARD TEST

MACRO-VUE RUBELLA CARD TEST is an FDA 510(k)-cleared medical device (K800797) 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 19, 1980. Regulation: 8.