Kit, Identification, Mycobacteria

How Is JSY Classified?

Kit, Identification, Mycobacteria is FDA product code JSY, Class 1, 21 CFR 866.2660.

How Does It Reach the US Market?

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 2009. None was by a company in China. The root cause the FDA records most often is Error in labeling (1).

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