
Immunalysis Corporation
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Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets is an FDA 510(k)-cleared medical device (K151395) 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 July 23, 2015. Regulation: 8.