BIOTEST ANTI-EBV RECOMBINANT, EA IGM

BIOTEST ANTI-EBV RECOMBINANT, EA IGM is an FDA 510(k)-cleared medical device (K983842) manufactured by Biotest Diagnostics Corp.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 8, 1999. Regulation: 8.