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Cepheid: FDA 510(k), CLIA Waiver for Point-of-Care Flu Test

Cepheid’s CPHD rapid influenza and RSV assay – the Xpert Flu+RSV Xpress test – recently won the U.S. FDA 510(k) marketing approval and the Clinical Laboratory Improvement Achievements (CLIA) waiver.
Business Insider

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu Test

SUNNYVALE, Calif., Jan. 9, 2018 /PRNewswire/ -- Cepheid announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) ...
Nasdaq

Cepheid: FDA 510(k), CLIA Waiver for Point-of-Care Flu Test

Cepheid 's CPHD rapid influenza and RSV assay - the Xpert Flu+RSV Xpress test - recently won the U.S. FDA 510(k) marketing approval and the Clinical Laboratory Improvement Achievements (CLIA) waiver.
Business Insider

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert Xpress Strep A

SUNNYVALE, Calif., May 2, 2018 /PRNewswire/ -- Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and waiver under the Clinical Laboratory ...