FDA Product Code NBW: System, Test, Blood Glucose, Over The Counter

FDA product code NBW covers over-the-counter blood glucose test systems for home use by people with diabetes.

These systems — comprising a meter and test strips — allow patients to measure their blood glucose level from a small fingertip blood sample in seconds. Results guide insulin dosing decisions, dietary choices, and the management of hypoglycemic and hyperglycemic episodes.

NBW devices are Class II medical devices, regulated under 21 CFR 862.1345 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Apex BioTechnology Corp., Bionime Corporation and I-Sens, Inc..