FDA device listing
iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE,iSCREEN™ Oral Fluid Test Drug Screen Swab,iSCREEN™ ORAL FLUID TEST DRUG SCREEN…
FDA device listing 1339025448 · GUANGZHOU WONDFO BIOTECH CO., LTD.
Key facts
| Proprietary names | iSCREEN™ ORAL FLUID TEST DRUG SCREEN CUBE,iSCREEN™ Oral Fluid Test Drug Screen Swab,iSCREEN™ ORAL FLUID TEST DRUG SCREEN SWAB,Prime Screen® One Step Multi-Drug Oral Fluid Test,SAFElife™ T-Square Multi-Drug Oral Fluid Test,SAFElife™ T-Swab Multi-Drug Oral Fluid Test,STATSWAB® III Oral Fluid Drug Test |
|---|---|
| Owner/operator | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| Owner/operator number | 9064561 |
| Product codes | PVJ |
| Device names | PVJ - Test, Cannabinoid, Employment And Insurance Testing, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3870 |
| Review panels | Clinical Toxicology |
| Registered establishments | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| Establishment registrations | 3004635103, 3023322455 |
| FEI numbers | 3004635103, 3023322455 |
| 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