FDA device listing
Amazewell™ D-Pen™ Oral Fluid Drug Test,Amazewell™ Lollipop Oral Fluid Drug Test,CVSHealth® 6 Drugs Oral Test Kit,MGC…
FDA device listing 1437750850 · Guangzhou Decheng biotechnology co., Ltd.
Key facts
| Proprietary names | Amazewell™ D-Pen™ Oral Fluid Drug Test,Amazewell™ Lollipop Oral Fluid Drug Test,CVSHealth® 6 Drugs Oral Test Kit,MGC HEALTH™ D-PEN™ ORAL FLUID DRUG TEST,UScreen Oral® Saliva Drug Test Pen |
|---|---|
| Owner/operator | Guangzhou Decheng biotechnology co., Ltd. |
| Owner/operator number | 10079520 |
| Product codes | PVH |
| Device names | PVH - Test, Opiates, Employment And Insurance Testing, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3650 |
| Review panels | Clinical Toxicology |
| Registered establishments | Guangzhou Decheng Biotechnology Co., Ltd. |
| Establishment registrations | 3017904598 |
| FEI numbers | 3017904598 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database