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WNV diagnostics

This article was originally published in The Gray Sheet

Executive Summary

FDA issues a 1Class II special controls guidance for WNV assays Oct. 30 in the wake of PanBio's Capture lab test de novo 510(k) clearance (2"The Gray Sheet" July 14, 2003, p. 21). The guidance addresses premarket requirements for the WNV IgM Elisa assay, including labeling and performance study information...

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