MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM

MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM is an FDA 510(k)-cleared medical device (K951709) 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 6, 1996. Regulation: 8.