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.
PharmiWeb

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 ResultsSAN JOSE, Calif.--(BUSINESS WIRE)--Today, Visby Medical announced two new relationships that will ...
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 ...
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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 ...