Reagents, Clostridium Difficile Toxin

How Is LLH Classified?

Reagents, Clostridium Difficile Toxin is FDA product code LLH, 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 Has Gone Wrong With It?

The FDA has recorded 11 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (5), Material/Component Contamination (2) and Error in labeling (1).

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