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Immunohistochemical stains

This article was originally published in The Gray Sheet

Executive Summary

IHC stains used as aids in diagnosis are unanimously recommended for Class II status by FDA's Hematology and Pathology Devices Advisory Panel at an Oct. 21 meeting in Gaithersburg, Maryland. In a 9-0 vote, the panel said that special controls should consist of voluntary standards and an FDA points-to- consider document. FDA issued a draft points-to-consider document July 20 on IHC stains, which currently are unclassified ("The Gray Sheet" Aug. 1, p. 2). The panel did not make a classification recommendation for IHC stains used as stand-alone diagnostic tests



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