MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM

MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM is an FDA 510(k)-cleared medical device (K950829) manufactured by Mardx Diagnostics, 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 June 4, 1996. Regulation: 8.