Tina-quant C-Reactive Protein IV

Tina-quant C-Reactive Protein IV is an FDA 510(k)-cleared medical device (K192072) manufactured by Roche Diagnostics Operations (Rdo). This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2020. Regulation: 8.