
DiaSorin, Inc.
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LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET is an FDA 510(k)-cleared medical device (K993669) manufactured by DiaSorin, 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 November 16, 1999. Regulation: 8.