FDA device listing
CHORUS CLIA FECAL ELASTASE,CHORUS ELASTASE COPROCOLLECT,CHORUS FECAL ELASTASE
FDA device listing 1927130435 · DIESSE DIAGNOSTICA SENESE S.P.A
Key facts
| Proprietary names | CHORUS CLIA FECAL ELASTASE,CHORUS ELASTASE COPROCOLLECT,CHORUS FECAL ELASTASE |
|---|---|
| Owner/operator | DIESSE DIAGNOSTICA SENESE S.P.A |
| Owner/operator number | 9038779 |
| Product codes | JNN |
| Device names | JNN - P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1725 |
| Review panels | Clinical Chemistry |
| Registered establishments | DIESSE DIAGNOSTICA SENESE S.P.A |
| Establishment registrations | 9615056 |
| FEI numbers | 1000186023 |
| 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