FDA device listing
Multi-Analyte Set D Drug of Abuse Calibrators,Multi-Analyte Set E Drug of Abuse Calibrators,Multi-Analyte Set F Drug of…
FDA device listing 2014613754 · LIN-ZHI INTERNATIONAL, INC.
Key facts
| Proprietary names | Multi-Analyte Set D Drug of Abuse Calibrators,Multi-Analyte Set E Drug of Abuse Calibrators,Multi-Analyte Set F Drug of Abuse Calibrators |
|---|---|
| Owner/operator | LIN-ZHI INTERNATIONAL, INC. |
| Owner/operator number | 9049436 |
| Product codes | DKB |
| Device names | DKB - Calibrators, Drug Mixture |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3200 |
| Review panels | Clinical Toxicology |
| Registered establishments | LIN-ZHI INTERNATIONAL, INC. |
| Establishment registrations | 3003610499 |
| FEI numbers | 3003610499 |
| Establishment operations | 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