
Hemagen Diagnostics, Inc.
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HEMAGEN ENA SCL-70 KIT (EIA METHOD) is an FDA 510(k)-cleared medical device (K915282) manufactured by Hemagen Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 11, 1992. Regulation: 8.