MARDX LYME DISEASE IFA (IGM) TEST SYSTEM

MARDX LYME DISEASE IFA (IGM) TEST SYSTEM is an FDA 510(k)-cleared medical device (K894609) manufactured by Mardx, 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 18, 1989. Regulation: 8.