LZI Cotinine II Enzyme Immunoassay

LZI Cotinine II Enzyme Immunoassay is an FDA 510(k)-cleared medical device (K192299) manufactured by Lin-Zhi International, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 20, 2019. Regulation: 8.