FDA device listing
S1887, Pointe Cortisol Enzyme Immunoassay
FDA device listing 1920912439 · HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
Key facts
| Proprietary names | S1887, Pointe Cortisol Enzyme Immunoassay |
|---|---|
| Owner/operator | HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical |
| Owner/operator number | 10083022 |
| Product codes | CHA |
| Device names | CHA - Radioimmunoassay, Corticosterone |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1200 |
| Review panels | Clinical Chemistry |
| Registered establishments | HORIBA INSTRUMENTS INCORPORATED |
| Establishment registrations | 1827821 |
| FEI numbers | 1827821 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| 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