FDA Product Code DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cocaine use disorder and acute intoxication require rapid laboratory confirmation. FDA product code DIO covers enzyme immunoassay systems for cocaine and cocaine metabolite detection.
These tests detect benzoylecgonine — the primary urinary metabolite of cocaine — in biological specimens. They are used in emergency toxicology screening, workplace drug testing, and substance abuse treatment monitoring.
DIO devices are Class II medical devices, regulated under 21 CFR 862.3250 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Microgenics Corporation, Immunalysis Corporation and Guangzhou Wondfo Biotech Co., Ltd..
List of Enzyme Immunoassay, Cocaine And Cocaine Metabolites devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Cocaine And Cocaine Metabolites devices (product code DIO). 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 →