Immunoglobulin M Lambda Heavy And Light Chain Combined
The Immunoglobulin M Lambda Heavy and Light Chain Combined assay is an immunology in vitro diagnostic device intended for the in vitro quantification of IgM lambda concentration in human serum, with results to be used in conjunction with previous test results and clinical information. It falls under the Immunology medical specialty and is classified as a Class 2 device under regulation 866.5510, requiring 510(k) premarket notification. These assays support diagnosis and monitoring of monoclonal IgM disorders. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
Definition
Intended for the in-vitro quantification of IgM lambda concentration in human serum. The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.