
Roche Diagnostics Operations (Rdo)
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Tina-quant Transferrin ver.2 (urine application) is an FDA 510(k)-cleared medical device (K182095) 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 November 4, 2018. Regulation: 8.