RUBELLA LATEX CARD TEST

RUBELLA LATEX CARD TEST is an FDA 510(k)-cleared medical device (K811637) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 12, 1981. Regulation: 8.