Product code PCO
- Device name
- Immunoglobulin G Lambda Heavy And 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 IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings.
- Source
- FDA openFDA device classification dataset
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| 05051700016988 | Hevylite IgG Lambda Kit for Siemens BNII | THE BINDING SITE GROUP LIMITED | 2016-09-24 |