BARTELS TOXOPLASMA IGM EIA

BARTELS TOXOPLASMA IGM EIA is an FDA 510(k)-cleared medical device (K922579) 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 1, 1992. Regulation: 8.