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Roche Diagnostics Corp.
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ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 is an FDA 510(k)-cleared medical device (K040431) 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 March 9, 2004. Regulation: 8.