SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay

SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay is an FDA 510(k)-cleared medical device (K203564) manufactured by Immunalysis 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 December 21, 2021. Regulation: 8.