Data / Medical devices / Test, Amphetamine, Over The Counter / United States
FDA-registered makers of Test, Amphetamine, Over The Counter in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Test, Amphetamine, Over The Counter (product code NFT). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Test, Amphetamine, Over The Counter
- Product code
- NFT
- Country
- United States
Makers of Test, Amphetamine, Over The Counter in the United States
| 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 |
| 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 |
| Healgen Scientific LLC | Houston, TX, United States | 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 |
| Boston Easy Biotech Inc | Belmont, MA, United States | Specification developer | 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 |
| 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 |
| Alfa Scientific Designs, Inc. | Poway, CA, United States | Contract manufacturer, 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 | |
| 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 | |
| W.H.P.M., Inc. | Irwindale, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.