FDA device listing
Biuret (colorimetric), Total Protein
FDA device listing 1006277712 · Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti
Key facts
| Proprietary names | Biuret (colorimetric), Total Protein |
|---|---|
| Owner/operator | Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti |
| Owner/operator number | 10060275 |
| Product codes | CEK |
| Device names | CEK - Biuret (Colorimetric), Total Protein |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1635 |
| Review panels | Clinical Chemistry |
| Registered establishments | DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI |
| Establishment registrations | 3011989923 |
| FEI numbers | 3011989923 |
| Establishment operations | Foreign Exporter |
| 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