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Data / Medical devices / Test, Amphetamine, Over The Counter

Test, Amphetamine, Over The Counter (NFT): 36 FDA-registered makers in 5 countries

36 establishments in 5 countries are registered with the FDA to make Test, Amphetamine, Over The Counter (product code NFT, Class 2, 21 CFR 862.3100). 24 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on September 10, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
NFT
Device class
2
Regulation
862.3100
Medical specialty
Clinical Toxicology

Makers by country

CountryMakers
China20
United States13
Canada1
Australia1
Indonesia1

Makers of Test, Amphetamine, Over The Counter

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Assure Tech LLCWilmington, DE, United StatesRepackager or relabeler, Specification developer5August 15, 2025000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Manufacturer, Specification developer5August 15, 2025000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer5August 15, 2025000api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer4April 4, 2025000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer4April 4, 2025000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer4April 28, 2026000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer4April 28, 2026000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer4April 4, 2025000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer4April 4, 2025000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer4April 4, 2025000api.fda.gov
Vivachek Biotech (hangzhou) Co., LtdHangzhou, Zhuji Zhejiang, ChinaManufacturer4May 22, 2026000api.fda.gov
Safecare Biotech(hangzhou)co.,ltdHuzhou Zhejiang, ChinaManufacturer3March 24, 2021000api.fda.gov
Hangzhou Aichek Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer2October 1, 2024000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer2August 30, 2022000api.fda.gov
Healstone Biotech Inc.Vancouver British Columbia, CanadaComplaint file establishment, Specification developer2August 30, 2022000api.fda.gov
Advin Biotech, Inc.San Diego, CA, United StatesManufacturer1October 9, 2025000api.fda.gov
Bioteke Corporation (wuxi) Co., LtdWuxi City Jiangsu, ChinaManufacturer1September 10, 2026000api.fda.gov
Boston Easy Biotech IncBelmont, MA, United StatesSpecification developer1November 9, 2018000api.fda.gov
Eterbio, Inc.Zhuhai Guangdong, ChinaManufacturer1November 9, 2018000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1February 27, 2025000api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer1August 27, 2025000api.fda.gov
Medical Disposables CorpOrlando, FL, United StatesComplaint file establishment, Manufacturer for export, Repackager or relabeler1April 5, 2018000api.fda.gov
Qingdao Hightop Biotech Co., Ltd.Qingdao Shandong, ChinaManufacturer1May 5, 2022000api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.Beijing, ChinaManufacturer1February 5, 2018000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Anhui Deepblue Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Co-Innovation Biotech Co.,ltd.Guangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
Guangzhou Decheng Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Hangzhou Biotest Biotech Co.,Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Innovation Scientific Pty LtdVineyard New South Wales, AustraliaContract manufacturer0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Mlife Diagnostics LLCMarshall, TX, United StatesContract manufacturer0000api.fda.gov
PT. Jayamas Medica Industri TBKJombang Jawa Timur, IndonesiaContract manufacturer0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated September 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.