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Inova Diagnostics, Inc.
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QUANTA LITE SP100 ELISA is an FDA 510(k)-cleared medical device (K050662) manufactured by Inova Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2005. Regulation: 8.