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 ...
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.
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 ...
FOX31 Denver

FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test

Test Enables Single-Visit Testing and Treatment for Hepatitis C SILVER SPRING, Md., June 27, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration granted marketing authorization to ...
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 ...
Seeking Alpha

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

Multiplex Vaginal Panel (MVP) delivers faster identification of three distinct conditions within an hour SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received ...