Immunoglobulin M Kappa 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 kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.