FDA device listing
Optilite CH50 Reagent Optilite CH50 Controls Optilite CH50 Calibrator
FDA device listing 1857418276 · THE BINDING SITE
Key facts
| Proprietary names | Optilite CH50 Reagent Optilite CH50 Controls Optilite CH50 Calibrator |
|---|---|
| Owner/operator | THE BINDING SITE |
| Owner/operator number | 9008308 |
| Premarket submissions | K150412 |
| Product codes | DAE, JIX, JJY |
| Device names | DAE - Complement C9, Antigen, Antiserum, Control, JIX - Calibrator, Multi-Analyte Mixture, JJY - Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 866.5240 |
| Review panels | Clinical Chemistry, Immunology |
| Registered establishments | THE BINDING SITE, The Binding Site Group Ltd. |
| Establishment registrations | 9614373, 3012471076 |
| FEI numbers | 3002808340, 3012471076 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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