FDA Product Code DJG: Enzyme Immunoassay, Opiates

Accurate detection of opioid use is essential in clinical toxicology, emergency medicine, and workplace drug testing. FDA product code DJG covers enzyme immunoassay systems for the detection of opiates in biological specimens.

These tests use antibody-based technology to identify the presence of opioids — including morphine, codeine, and related compounds — in urine or other samples. They are widely used as initial screening tools before confirmatory testing.

DJG devices are Class II medical devices, regulated under 21 CFR 862.3650 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Lin-Zhi International, Inc., Immunalysis Corporation and Guangzhou Wondfo Biotech Co., Ltd..