Antigens, All Groups, Streptococcus Spp.

How Is GTY Classified?

Antigens, All Groups, Streptococcus Spp. is FDA product code GTY, Class 1, 21 CFR 866.3740.

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 20 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are No Marketing Application (8), Process change control (2) and Process control (2).

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