VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack is an FDA 510(k)-cleared medical device (K201312) manufactured by Ortho Clinical Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 2021. Regulation: 8.