# Bioteke Corporation (Wuxi) Co., Ltd (manufacturer, Wuxi City Jiangsu, CN): 10 new FDA device listings, incl. test, opiates, over the counter

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Bioteke Corporation (Wuxi) Co., Ltd |
| Owner / operator | BioTeke Corporation (Wuxi) Co., Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Wuxi City Jiangsu, CN |
| New listings | 10 |
| Devices | Test, Opiates, Over The Counter; Test, Phencyclidine (Pcp), Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Barbiturate, Over The Counter; Test, Amphetamine, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Cannabinoid, Over The Counter; Test, Methadone, Over The Counter; Test, Methamphetamine, Over The Counter |
| Product codes | NGL, NGM, NFV, PTH, NFT, QAW, NFY, NFW, PTG, NGG |
| Device classes | Class II, Unclassified |
| Medical specialties | Clinical Toxicology |
| Brand names | BioTeke® Multi-Drug Urine Test Cup |
| First new listing | 2026-09-17 |
| Latest new listing | 2026-09-17 |
| FDA registration number | 3016837106 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.