FDA Product Code NBC: Test, Natriuretic Peptide

Under FDA product code NBC, natriuretic peptide tests are cleared for the diagnosis and monitoring of heart failure.

These assays measure BNP (brain natriuretic peptide) or NT-proBNP levels in blood — biomarkers released by cardiac muscle cells in response to increased wall stress. Elevated levels indicate heart failure and correlate with disease severity, making them essential in emergency and outpatient cardiology.

NBC devices are Class II medical devices, regulated under 21 CFR 862.1117 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Roche Diagnostics, Beckman Coulter, Inc. and Axis-Shield Diagnostics, Ltd..