Product code OPY
- Device name
- Igal Heavy & Light Chain Combined
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5510
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Intended for the in-vitro quantification of iga lambda 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.
- Source
- FDA openFDA device classification dataset
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 05051700017992 | Hevylite Human IgA Lambda SPA Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700018494 | Optilite Hevylite® IgA Lambda Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |