Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is an FDA 510(k)-cleared medical device (K191638) manufactured by Medtest DX. 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 March 11, 2020. Regulation: 8.