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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.
Nasdaq

Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This ...
Medindia

Cepheid Announces FDA Clearance Of Xpert® Xpress Flu And Xpert Xpress Flu/RSV

SUNNYVALE, Calif., Feb. 15, 2017 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Flu and Xpert Xpress ...
Healio

FDA clears first ‘rapid diagnostic’ hepatitis C RNA test for point-of-care settings

Please provide your email address to receive an email when new articles are posted on . The FDA granted marketing authorization for Cepheid’s Xpert HCV test and GeneXpert Xpress System, the first ...