TEST, MONO., CARD (MACRO-VUE)

TEST, MONO., CARD (MACRO-VUE) is an FDA 510(k)-cleared medical device (K760040) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 1976. Regulation: 8.