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 ...
Seeking Alpha

Cepheid Receives FDA Clearance for Xpert® Xpress GBS

Redesigned test introduces two new targets to improve coverage and sensitivity for Group B Streptococcus intrapartum testing for pregnant females Group B Streptococcus (GBS) is the leading cause of ...