ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT

ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K844167) 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 November 26, 1984. Regulation: 8.