HEMAGEN CHAGAS' KIT (EIA METHOD)

HEMAGEN CHAGAS' KIT (EIA METHOD) is an FDA 510(k)-cleared medical device (K930272) manufactured by Hemagen Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 18, 1995. Regulation: 8.