DRI Benzodiazepine Assay

DRI Benzodiazepine Assay is an FDA 510(k)-cleared medical device (K173963) 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 February 20, 2018. Regulation: 8.