
Inova Diagnostics, Inc.
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QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA is an FDA 510(k)-cleared medical device (K003959) 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 January 21, 2001. Regulation: 8.