
Hemagen Diagnostics, Inc.
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VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT is an FDA 510(k)-cleared medical device (K992224) 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 August 29, 1999. Regulation: 8.