Indirect Copper Assay, Ceruloplasmin

What Is FDA Product Code JFR?

Indirect Copper Assay, Ceruloplasmin is FDA product code JFR, Class 2, 21 CFR 866.5210.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.