Immunoglobulin M 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 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.