NRX

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Product code

NRX

Device name

Complement 4d (C4d) And Complement Receptor 1 (Cr1)

Device class

Class 2

21 CFR

21 CFR 866.5820

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus.

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