BARTELS RUBELLA IGG EIA

BARTELS RUBELLA IGG EIA is an FDA 510(k)-cleared medical device (K922586) 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 September 16, 1992. Regulation: 8.