Radioimmunoassay, Estriol

What Is FDA Product Code CGI?

Radioimmunoassay, Estriol is FDA product code CGI, Class 1, 21 CFR 862.1265.

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.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2009. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.