
The Binding Site, Ltd.
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BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT is an FDA 510(k)-cleared medical device (K991801) 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 May 4, 2000. Regulation: 8.