Cepheid Receives FDA Clearance for Xpert® GI Panel to Support Broad Detection of Gastrointestinal Pathogens

Cepheid announced today that it has received FDA clearance for Xpert GI Panel, a multiplex PCR test designed to provide fast ...
GlobalData on MSN

FDA clears Cepheid’s Xpert GI Panel for pathogen detection

The Xpert GI Panel identifies pathogens directly from stool specimens collected in Cary-Blair transport media.
Business Wire

Minute Molecular’s DASH Point-of-Care COVID-19 Rapid PCR Test Gains FDA Emergency Use Authorization

EVANSTON, Ill.--(BUSINESS WIRE)--Minute Molecular Diagnostics today announced that the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for its rapid DASH ...
ABC News

FDA authorizes 1st COVID-19 'breathalyzer' test

Results are detected within just a few minutes, the agency said. The Food and Drug Administration has granted emergency use authorization for a COVID-19 test that uses breath samples -- the first of ...
6abc News

FDA authorizes 1st COVID-19 antigen test, which produces results within minutes

The Food and Drug Administration has authorized emergency use of the first antigen coronavirus test, which produces results within minutes and is relatively cheap to make, according to the agency. The ...
360Dx

Cepheid Enters Rapid Syndromic Testing Space With FDA Clearance of GI Panel

The Danaher subsidiary aims to meet clinician needs for flexibility with a range of test size options for its vast installed base.
Business Wire

QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test

SAN DIEGO--(BUSINESS WIRE)--QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 ...
Seeking Alpha

Roche's first respiratory test powered by TAGS technology receives FDA clearance for SARS-CoV-2, Influenza A, Influenza B and RSV

Used with the cobas ® 5800, 6800 and 8800 systems, cobas Respiratory 4-flex simultaneously detects and differentiates the four most common respiratory viruses, helping to ensure confidence in ...
Yahoo

Roche’s test for Bordetella infections gains FDA clearance

Add Yahoo as a preferred source to see more of our stories on Google. Roche’s test is intended for diagnosing pertussis and other Bordetella infections. Credit: Hafizgnwn / Shutterstock.com.
ABC 7 Chicago

FDA authorizes first breath test to detect COVID-19

WASHINGTON -- The US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency ...
Morningstar

Visby Engages Quest and Labcorp to Broaden Consumer Access to First At-Home, FDA-Authorized PCR Test for STIs

Consumers Now Have More Choices to Purchase the Visby Device Featuring 30-Minute, Lab-Quality Results Today, Visby Medical announced two new relationships that will expand national access to the Visby ...
pix11

Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™ PCR Platform to Support Submission to the U.S. FDA

SALT LAKE CITY, Nov. 18, 2025 /PRNewswire/ --Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of ...