MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM

MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM is an FDA 510(k)-cleared medical device (K892206) 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 August 14, 1989. Regulation: 8.