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 ...
Morningstar

FDA Approves Danaher Unit's Rapid Test for Hepatitis C

The Food and Drug Administration on Thursday granted marketing approval to Danaher's Cepheid unit for a rapid test for hepatitis C. The approval is for Cepheid's Xpert HCV test and GeneXpert Xpress ...
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 Emergency Use Authorization from FDA for Xpert® Mpox

SUNNYVALE, Calif., Feb. 14, 2023 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for Xpert Mpox, which runs on ...
BioWorld

Items Tagged with 'Genexpert'

The Xpert MTB/XDR test developed by the Foundation for Innovative New Diagnostics (FIND) and Cepheid Inc. quickly indicates whether a patient has a dangerous – and rapidly increasing – strain of ...
Nasdaq

Cepheid Receives Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV Combination Test

SUNNYVALE, Calif., Sept. 29, 2020 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress ...