Immunalysis Tapentadol Urine HEIA

Immunalysis Tapentadol Urine HEIA is an FDA 510(k)-cleared medical device (K203527) manufactured by Lmmunalysis 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 May 8, 2022. Regulation: 8.