FDA Product Code NGL: Test, Opiates, Over The Counter
Point-of-care opiate testing enables rapid results in emergency and clinical settings without laboratory infrastructure. FDA product code NGL covers over-the-counter opiate tests for consumer use.
These lateral flow immunoassay devices provide a rapid, visual result for the presence of opiates in urine without laboratory equipment. They are used in home monitoring, workplace screening, and community settings.
NGL devices are Class II medical devices, regulated under 21 CFR 862.3650 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Healgen Scientific, LLC and Guangzhou Wondfo Biotech Co., Ltd..
List of Test, Opiates, Over The Counter devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Test, Opiates, Over The Counter devices (product code NGL). 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 →