FDA Product Code NFT: Test, Amphetamine, Over The Counter
Point-of-care amphetamine testing enables rapid results in non-laboratory settings. FDA product code NFT covers over-the-counter amphetamine tests for consumer or near-patient use.
These lateral flow immunoassay devices provide a rapid, visual result for the presence of amphetamines in urine without laboratory equipment, enabling rapid screening in occupational health, emergency, and community settings.
NFT devices are Class II medical devices, regulated under 21 CFR 862.3100 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Guangzhou Wondfo Biotech Co., Ltd., Vivachek Biotech (Hangzhou) Co., Ltd. and Hangzhou AllTest Biotech Co., Ltd..
30
Total
30
Cleared
60d
Avg days
2017
Since
30 devices
Cleared
Nov 09, 2018
BIOEASY Multi-Drug Test Cup
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology
56d
Cleared
Aug 20, 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology
48d
Cleared
Aug 20, 2018
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology
27d
Cleared
Apr 05, 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology
56d
Cleared
Feb 05, 2018
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
W.H.P.M., Inc.
Toxicology
243d