FDA Product Code GKZ: Counter, Differential Cell

FDA product code GKZ covers differential cell counters used in hematology laboratories.

These automated or semi-automated instruments classify and count white blood cell subtypes — neutrophils, lymphocytes, monocytes, eosinophils, and basophils — from blood smears or liquid samples. The differential count is a critical component of the complete blood count used to diagnose infections, hematological disorders, and immune conditions.

GKZ devices are Class II medical devices, regulated under 21 CFR 864.5220 and reviewed by the FDA Hematology panel.

Leading manufacturers include Sysmex America, Inc., Abbott Laboratories and Beckman Coulter, Inc..