Kit, Identification, Neisseria Gonorrhoeae
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jiangsu: 2 hold an FDA registration.
What Is FDA Product Code JSX?
Kit, Identification, Neisseria Gonorrhoeae is FDA product code JSX, 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 2025. 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.