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Herpes virus special controls

This article was originally published in The Gray Sheet

Executive Summary

FDA finalizes a proposal to down-classify Type 1 and 2 herpes simplex virus serological assays from Class III to Class II medical devices in an April 3 final rule and special controls 1guidance (2"The Gray Sheet" Jan. 16, 2006, In Brief). HSV serological assays for other than Types 1 and 2 remain Class III devices...

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