BARTELS CYTOMEGALOVIRUS IGM EIA

BARTELS CYTOMEGALOVIRUS IGM EIA is an FDA 510(k)-cleared medical device (K922580) manufactured by Baxter 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 7, 1993. Regulation: 8.