PDE

Immunoglobulin M Kappa Heavy And Light Chain Combined

Product code

PDE

Device name

Immunoglobulin M Kappa Heavy And Light Chain Combined

Device class

Class 2

21 CFR

21 CFR 866.5510

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).