PDE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunoglobulin M Kappa Heavy And Light Chain Combined
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA definition
- Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
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| Record | Firm | Date |
|---|---|---|
| Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit (K152389) | The Binding Site Group , Ltd. | 2015-12-18 |
| HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS (K140686) | The Binding Site Group , Ltd. | 2014-08-06 |
Track PDE automatically
Every clearance here is in the API, with alerts when new ones post.