Emit® II Plus Buprenorphine Assay

Emit® II Plus Buprenorphine Assay is an FDA 510(k)-cleared medical device (K221605) manufactured by Siemens Healthcare Diagnostics, 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 July 24, 2023. Regulation: 8.