FDA device listing
Methadone Metabolite DAU Calibrators,Methadone Metabolite DAU Controls,Methadone Metabolite Enzyme Immunoassay
FDA device listing 1501068390 · LIN-ZHI INTERNATIONAL, INC.
Key facts
| Proprietary names | Methadone Metabolite DAU Calibrators,Methadone Metabolite DAU Controls,Methadone Metabolite Enzyme Immunoassay |
|---|---|
| Owner/operator | LIN-ZHI INTERNATIONAL, INC. |
| Owner/operator number | 9049436 |
| Premarket submissions | K031797 |
| Product codes | DJR, DLJ |
| Device names | DJR - Enzyme Immunoassay, Methadone, DLJ - Calibrators, Drug Specific |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3200, 862.3620 |
| 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
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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