
Medix Biotech, Inc.
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IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 is an FDA 510(k)-cleared medical device (K922047) manufactured by Medix Biotech, 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 4, 1992. Regulation: 8.