Antisera, Latex Agglutination, Cryptococcus Neoformans

What Is FDA Product Code GMD?

Antisera, Latex Agglutination, Cryptococcus Neoformans is FDA product code GMD, Class 2, 21 CFR 866.3165.

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 3 recalls under this product code since 2016. None was by a company in China. The root causes the FDA records most often are Material/Component Contamination (2) and Nonconforming Material/Component (1).

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