FDA device listing
KT 881 EDI™ Human C-peptide ELISA Kit,KT 891 Serolisa™ High Sensitive Human C-Peptide ELISA Kit,SKT-023 Human C-peptide…
FDA device listing 1071344850 · EPITOPE DIAGNOSTICS, INC.
Key facts
| Proprietary names | KT 881 EDI™ Human C-peptide ELISA Kit,KT 891 Serolisa™ High Sensitive Human C-Peptide ELISA Kit,SKT-023 Human C-peptide CLIA Kit |
|---|---|
| Owner/operator | EPITOPE DIAGNOSTICS, INC. |
| Owner/operator number | 9059077 |
| Product codes | JKD |
| Device names | JKD - Radioimmunoassay, C-Peptides Of Proinsulin |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1135 |
| Review panels | Clinical Chemistry |
| Registered establishments | EPITOPE DIAGNOSTICS, INC. |
| Establishment registrations | 2032839 |
| FEI numbers | 3004185580 |
| 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