MARDX LYME DISEASE IGG IFA TEST SYSTEM

MARDX LYME DISEASE IGG IFA TEST SYSTEM is an FDA 510(k)-cleared medical device (K890053) 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 April 17, 1989. Regulation: 8.