HAPTOGLOBIN IMMUNOLOGICAL TEST KIT

HAPTOGLOBIN IMMUNOLOGICAL TEST KIT is an FDA 510(k)-cleared medical device (K913670) 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 December 8, 1991. Regulation: 8.