OPX

Immunoglobulin A Kappa Heavy & Light Chain Combined

Product code

OPX

Device name

Immunoglobulin A Kappa Heavy & 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)

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

FDA classification definition

Intended for the in-vitro quantification of iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.

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