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.
63
Total
63
Cleared
114d
Avg days
1984
Since
FDA 510(k) Cleared Enzyme Immunoassay, Methadone Devices (Product Code DJR)
63 devices
Cleared
Oct 04, 2019
LZI Methadone II Enzyme Immunoassay
Lin-Zhi International, Inc.
Toxicology
29d
Cleared
Jun 26, 2017
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
Lin-Zhi International, Inc.
Toxicology
136d
Cleared
Jul 24, 2015
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
Immunalysis Corporation
Toxicology
59d
About Product Code DJR - Regulatory Context
DJR devices are reviewed by the Toxicology panel. Browse all Toxicology devices →