Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set

Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set is an FDA 510(k)-cleared medical device (K150925) 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 June 28, 2015. Regulation: 8.