EBNA-1 IGM ELISA TEST SYSTEM

EBNA-1 IGM ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K982348) manufactured by Columbia Bioscience, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 24, 1998. Regulation: 8.