Immunohistochemistry Reagents and Kits

What Is This Device?

according to the regs…”..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.

How Is NJT Classified?

Immunohistochemistry Reagents And Kits is FDA product code NJT, Class 1, 21 CFR 864.1860.

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 92 recalls under this product code since 2005. None was by a company in China. 18 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (14), Process control (9) and Storage (7). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.