LZI Fentanyl III Enzyme Immunoassay

LZI Fentanyl III Enzyme Immunoassay is an FDA 510(k)-cleared medical device (K251634) manufactured by Lin-Zhi International, 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 June 17, 2025. Regulation: 8.