RHEUMATOID FACTOR TEST SYSTEMS

RHEUMATOID FACTOR TEST SYSTEMS is an FDA 510(k)-cleared medical device (K802688) 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 December 17, 1980. Regulation: 8.