FDA device listing
Diatro Dil 5P,Diatro Dil DIFF
FDA device listing 1042023545 · Diatron MI Plc
Key facts
| Proprietary names | Diatro Dil 5P,Diatro Dil DIFF |
|---|---|
| Owner/operator | Diatron MI Plc |
| Owner/operator number | 10040448 |
| Product codes | GIF |
| Device names | GIF - Diluent, Blood Cell |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.8200 |
| Review panels | Hematology |
| Registered establishments | Diatron MI Plc |
| Establishment registrations | 3009297077 |
| FEI numbers | 3009297077 |
| 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