NJW

Control Material, Her-2/Neu, Immunohistochemistry

Product code

NJW

Device name

Control Material, Her-2/Neu, Immunohistochemistry

Device class

Class 2

21 CFR

21 CFR 864.1860

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.

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