OPX
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunoglobulin A Kappa Heavy & 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 iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.
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| Record | Firm | Date |
|---|---|---|
| Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit (K160819) | The Binding Site Group , Ltd. | 2016-06-16 |
| Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS (K151759) | The Binding Site Group , Ltd. | 2015-11-06 |
| HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII (K140105) | The Binding Site | 2014-03-18 |
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Every clearance here is in the API, with alerts when new ones post.