FDA device listing
Sample Mixer,Sample Mixer 2
FDA device listing 1950791953 · Exact Sciences Corporation
Key facts
| Proprietary names | Sample Mixer,Sample Mixer 2 |
|---|---|
| Owner/operator | Exact Sciences Corporation |
| Owner/operator number | 10047364 |
| Product codes | JRO |
| Device names | JRO - Blender/Mixer |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | Exact Sciences Corporation- Discovery Campus, Exact Sciences Corporation- Innovation Campus, Exact Sciences Corporation- Legacy Campus |
| Establishment registrations | 3008256118, 3013841562, 3015728010 |
| FEI numbers | 3008256118, 3013841562, 3015728010 |
| 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