MMUNO DOT BORRELIA DOT BLOT M TEST

MMUNO DOT BORRELIA DOT BLOT M TEST is an FDA 510(k)-cleared medical device (K953683) manufactured by Genbio. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 2, 1996. Regulation: 8.