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
| Country | Makers |
|---|---|
| China | 20 |
| United States | 13 |
| Canada | 1 |
| Australia | 1 |
| Indonesia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Assure Tech LLC | Wilmington, DE, United States | Repackager or relabeler, Specification developer | 5 | August 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer, Specification developer | 5 | August 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 5 | August 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| ABOUND Diagnostics, Inc | San Diego, CA, United States | Specification developer | 4 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 4 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 4 | April 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 4 | April 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 4 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 4 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 4 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vivachek Biotech (hangzhou) Co., Ltd | Hangzhou, Zhuji Zhejiang, China | Manufacturer | 4 | May 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Safecare Biotech(hangzhou)co.,ltd | Huzhou Zhejiang, China | Manufacturer | 3 | March 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Aichek Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 2 | October 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 2 | August 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Healstone Biotech Inc. | Vancouver British Columbia, Canada | Complaint file establishment, Specification developer | 2 | August 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Advin Biotech, Inc. | San Diego, CA, United States | Manufacturer | 1 | October 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bioteke Corporation (wuxi) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 1 | September 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Easy Biotech Inc | Belmont, MA, United States | Specification developer | 1 | November 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Eterbio, Inc. | Zhuhai Guangdong, China | Manufacturer | 1 | November 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | February 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 1 | August 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medical Disposables Corp | Orlando, FL, United States | Complaint file establishment, Manufacturer for export, Repackager or relabeler | 1 | April 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Qingdao Hightop Biotech Co., Ltd. | Qingdao Shandong, China | Manufacturer | 1 | May 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| W.H.P.M. Bioresearch & Technology Co., Ltd. | Beijing, China | Manufacturer | 1 | February 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Alfa Scientific Designs, Inc. | Poway, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Deepblue Medical Technology Co., Ltd. | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Co-Innovation Biotech Co.,ltd. | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Biotest Biotech Co.,Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovation Scientific Pty Ltd | Vineyard New South Wales, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mlife Diagnostics LLC | Marshall, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Jayamas Medica Industri TBK | Jombang Jawa Timur, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W.H.P.M., Inc. | Irwindale, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.