FDA device listing
DRI Oxycodone Assay,DRI Oxycodone Assay for SYNCHRON Systems,Oxycodone DRI Automated Assay for Drug Abuse COBAS…
FDA device listing 1373448251 · Thermo Fisher Scientific
Key facts
| Proprietary names | DRI Oxycodone Assay,DRI Oxycodone Assay for SYNCHRON Systems,Oxycodone DRI Automated Assay for Drug Abuse COBAS INTEGRA/Cobas c systems,Oxycodone DRI Automated Assay for Drug Abuse Roche/Hitachi,OXY Oxycodone |
|---|---|
| Owner/operator | Thermo Fisher Scientific |
| Owner/operator number | 2517925 |
| Premarket submissions | K040411 |
| Product codes | DJG |
| Device names | DJG - Enzyme Immunoassay, Opiates |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3650 |
| Review panels | Clinical Toxicology |
| Registered establishments | Microgenics Corporation |
| Establishment registrations | 3010939897 |
| FEI numbers | 3010939897 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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