FDA device listing
Hevylite Human IgG Kappa Kit for use on SPAPLUS,Hevylite Human IgG Lambda Kit for use on SPAPLUS
FDA device listing 1128858699 · THE BINDING SITE
Key facts
| Proprietary names | Hevylite Human IgG Kappa Kit for use on SPAPLUS,Hevylite Human IgG Lambda Kit for use on SPAPLUS |
|---|---|
| Owner/operator | THE BINDING SITE |
| Owner/operator number | 9008308 |
| Premarket submissions | K161854 |
| Product codes | PCN, PCO |
| Device names | PCN - Immunoglobulin G Kappa Heavy And Light Chain Combined, PCO - Immunoglobulin G Lambda Heavy And Light Chain Combined |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5510 |
| Review panels | 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