FDA device listing
Onestep Methadone InstaTest
FDA device listing 1166158828 · Diagnostic Automation /Cortez Diagnostics Inc.
Key facts
| Proprietary names | Onestep Methadone InstaTest |
|---|---|
| Owner/operator | Diagnostic Automation /Cortez Diagnostics Inc. |
| Owner/operator number | 9011974 |
| Product codes | DJR |
| Device names | DJR - Enzyme Immunoassay, Methadone |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3620 |
| Review panels | Clinical Toxicology |
| Registered establishments | Diagnostic Automation/ Cortez Diagnostics Inc,. |
| Establishment registrations | 2029372 |
| FEI numbers | 1000306617 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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