
Hemagen Diagnostics, Inc.
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HEMAGEN ENA SCREENING KIT (EIA METHOD) is an FDA 510(k)-cleared medical device (K952076) 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 June 4, 1995. Regulation: 8.