IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K983605) manufactured by Columbia Bioscience, 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 December 15, 1998. Regulation: 8.