
The Binding Site, Ltd.
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HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY is an FDA 510(k)-cleared medical device (K001556) manufactured by The Binding Site, Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2000. Regulation: 8.