Giemsa Stain

How Is HYF Classified?

Giemsa Stain is FDA product code HYF, Class 1, 21 CFR 864.1850.

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. It is also exempt from most of the quality system regulation.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2017. None was by a company in China. The root cause the FDA records most often is Mixed-up of materials/components (1).

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