Data / Medical devices / Test, Methadone, Over The Counter
Test, Methadone, Over The Counter (PTG): 38 FDA-registered makers in 5 countries
38 establishments in 5 countries are registered with the FDA to make Test, Methadone, Over The Counter (product code PTG, Class 2, 21 CFR 862.3620). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PTG
- Device class
- 2
- Regulation
- 862.3620
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| China | 21 |
| United States | 14 |
| Canada | 1 |
| Australia | 1 |
| Indonesia | 1 |
Makers of Test, Methadone, 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 |
|---|---|---|---|---|---|---|---|---|
| ABOUND Diagnostics, Inc | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advin Biotech, Inc. | San Diego, CA, United States | Manufacturer | 0 | 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 | |
| Assure Tech LLC | Wilmington, DE, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioteke Corporation (wuxi) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Easy Biotech Inc | Belmont, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Co-Innovation Biotech Co.,ltd. | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Technology Co., Ltd. | Changping District Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CorDx, Inc. | Alpharetta, GA, United States | 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 | |
| Eterbio, Inc. | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | 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 Aichek Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healstone Biotech Inc. | Vancouver British Columbia, Canada | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, China | 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 | |
| Medical Disposables Corp | Orlando, FL, United States | Complaint file establishment, Manufacturer for export, Repackager or relabeler | 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 | |
| Qingdao Hightop Biotech Co., Ltd. | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safecare Biotech(hangzhou)co.,ltd | Huzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivachek Biotech (hangzhou) Co., Ltd | Hangzhou, Zhuji Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W.H.P.M. Bioresearch & Technology Co., Ltd. | Beijing, China | 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 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.