Test System, Nicotine, Cotinine, Metabolites

What Is FDA Product Code MRS?

Test System, Nicotine, Cotinine, Metabolites is FDA product code MRS, Class 1, 21 CFR 862.3220.

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 1 recall under this product code since 2020. None was by a company in China. The root cause the FDA records most often is No Marketing Application (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.