
Hybritech, Inc.
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TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- is an FDA 510(k)-cleared medical device (K863858) manufactured by Hybritech, 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 November 2, 1986. Regulation: 8.