MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY

MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY is an FDA 510(k)-cleared medical device (K983268) manufactured by Diagnostic Reagents, Inc.. 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 17, 1998. Regulation: 8.