QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024

QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 is an FDA 510(k)-cleared medical device (K991063) manufactured by Immunetics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 1999. Regulation: 8.