FDA Product Code JXM: Enzyme Immunoassay, Benzodiazepine
Benzodiazepine detection is essential in forensic toxicology, emergency medicine, and addiction treatment monitoring. FDA product code JXM covers enzyme immunoassay systems for benzodiazepine detection.
These tests use antibody-based technology to screen for benzodiazepines — including diazepam, lorazepam, and clonazepam — in urine and other biological specimens. They are widely used as initial screening tools before confirmatory chromatographic testing.
JXM devices are Class II medical devices, regulated under 21 CFR 862.3170 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Microgenics Corporation, Healgen Scientific, LLC and Immunalysis Corporation.
List of Enzyme Immunoassay, Benzodiazepine devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Benzodiazepine devices (product code JXM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Toxicology FDA review panel. Browse all Toxicology devices →