DRI TM Tricyclics Serum Tox Assay

DRI TM Tricyclics Serum Tox Assay is an FDA 510(k)-cleared medical device (K213875) manufactured by Microgenics Corporation. 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 December 20, 2022. Regulation: 8.