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Cepheid Flu Test Wins First CLIA Waiver For PCR Panel

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.

Cepheid’s Xpert Flu + RSV Express diagnostic won both 510(k) clearance

and a Clinical Laboratory Improvements Amendments waiver from FDA on Dec. 3, making it the first polymerase chain-reaction (PCR) panel test to achieve a CLIA waiver, the company said...

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