BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT

BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K981029) 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 July 19, 1998. Regulation: 8.