
Helix Diagnostics, Inc.
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DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM is an FDA 510(k)-cleared medical device (K980337) manufactured by Helix 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 May 11, 1998. Regulation: 8.