FDA device listing
DOA Saliva cup,Rapid Diagnostic Tests
FDA device listing 1888359724 · Assure Tech. (Hangzhou) Co., Ltd.
Key facts
| Proprietary names | DOA Saliva cup,Rapid Diagnostic Tests |
|---|---|
| Owner/operator | Assure Tech. (Hangzhou) Co., Ltd. |
| Owner/operator number | 10040710 |
| Product codes | PVK |
| Device names | PVK - Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3910 |
| Review panels | Clinical Toxicology |
| Registered establishments | Assure Tech. (Hangzhou) Co., Ltd., ASSURE TECH. (HANGZHOU) CO., LTD. |
| Establishment registrations | 3009585529, 3038560224 |
| FEI numbers | 3009585529, 3038560224 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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