FDA device listing
General Purpose Reaction Buffer,Optilite Sample Diluent 1,Optilite Sample Diluent 2,Optilite Sample Diluent 3,Optilite…
FDA device listing 1595802372 · THE BINDING SITE
Key facts
| Proprietary names | General Purpose Reaction Buffer,Optilite Sample Diluent 1,Optilite Sample Diluent 2,Optilite Sample Diluent 3,Optilite Special Wash 1 |
|---|---|
| Owner/operator | THE BINDING SITE |
| Owner/operator number | 9008308 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| 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
- 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