FDA Product Code DJR: Enzyme Immunoassay, Methadone

Methadone monitoring is essential in opioid use disorder treatment programs. FDA product code DJR covers enzyme immunoassay systems for methadone detection in biological specimens.

These tests use antibody-based technology to screen for methadone and its metabolites in urine, confirming medication adherence in opioid treatment programs and detecting illicit methadone use in forensic and clinical settings.

DJR devices are Class II medical devices, regulated under 21 CFR 862.3620 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Lin-Zhi International, Inc. and Immunalysis Corporation.