NJT

Immunohistochemistry Reagents And Kits

Product code: NJT
Device name: Immunohistochemistry Reagents And Kits
Device class: Class 1
21 CFR: 21 CFR 864.1860
Medical specialty: Hematology
Marketing pathway: 510(K) Exempt

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NJT

Classification and pathway per current FDA publications. Data from openFDA (CC0).