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Cepheid Flu Test Wins First CLIA Waiver For PCR Panel

This article was originally published in The Gray Sheet

Executive Summary

FDA granted both a 510(k) clearance and a waiver for point-of-care use to Cepheid’s Xpert Flu +RSV Express test – the first molecular-based, polymerase chain-reaction panel diagnostic to win a CLIA waiver.

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