Candida Species, Antibody Detection

What Is FDA Product Code LSG?

Candida Species, Antibody Detection is FDA product code LSG, Class 2, 21 CFR 866.3165.

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.