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Roche Diagnostics Corp.
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TINA-QUANT IGG GEN.2 is an FDA 510(k)-cleared medical device (K050113) manufactured by Roche Diagnostics Corp.. 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 7, 2005. Regulation: 8.