
Hycor Biomedical
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NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus is an FDA 510(k)-cleared medical device (K182479) manufactured by Hycor Biomedical. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 2018. Regulation: 8.