Tina-quant Cystatin C Gen.2

Tina-quant Cystatin C Gen.2 is an FDA 510(k)-cleared medical device (K161817) manufactured by Roche Diagnostics Operations (Rdo). 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 July 26, 2016. Regulation: 8.