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, Axis-Shield Diagnostics, Ltd. and Ortho-Clinical Diagnostics.
List of Test, Natriuretic Peptide devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Test, Natriuretic Peptide devices (product code NBC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →