Kit, Direct Antigen, Positive Control

What Is FDA Product Code MJZ?

Kit, Direct Antigen, Positive Control is FDA product code MJZ, Class 1, 21 CFR 862.1660.

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.