GlobalData on MSN

LEX Diagnostics secures FDA clearance for VELO PCR system

The system is intended for use in urgent care clinics, primary care settings, physician office laboratories, and pharmacies.
Arizona Daily Star

GenoSensor Granted FDA Emergency Use Authorization for High Throughput COVID-19 RT-PCR Diagnostic for Use in U.S.

“The GS™ COVID-19 RT-PCR KIT is a much-needed addition to the tool set that communities across the country are using to respond to the COVID-19 health emergency,” stated Joan Koerber-Walker, President ...
Verywell Health on MSN

PCR vs. rapid test for COVID-19: Which should you take?

Medically reviewed by Jordana Haber Hazan, MD Key Takeaways PCR tests are very accurate and can find the virus even in people without symptoms.Rapid tests can be done at home and show results in ...
Morningstar

Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health

The Visby Medical Women's Sexual Health Test represents a significant milestone as the first-ever PCR (polymerase chain reaction) diagnostic device approved by the FDA for OTC home use for any ...
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 ...
Business Weekly

FDA clearance and CLIA waived status for LEX Diagnostics platform

LEX Diagnostics, a Cambridgeshire-based innovator in molecular diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA waived status for a platform that could ...
Seeking Alpha

Co-Diagnostics, Inc. Completes Submission to FDA for Co-Dx PCR Pro

The Company's Emergency Use Authorization submission is for the new Co-Dx PCR Pro instrument and COVID-19 test kit, designed for point-of-care and at-home. The menu of tests in development for the ...
Monthly Prescribing Reference

FDA Clears OTC Test for Chlamydia, Gonorrhea and Trichomoniasis

Credit: Visby Medical. The approval was based on a clinical study that included 2203 females aged 14 years and older. The Food and Drug Administration (FDA) has cleared the Visby Medical Women’s ...
Seeking Alpha

Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform

The Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the pipeline to meet the needs of a global market SALT LAKE CITY, ...
FierceBiotech

Visby Medical nets FDA clearance for completely at-home STI test

The FDA has cleared its first completely at-home sexual health test for women, available over-the-counter to screen for chlamydia, gonorrhea and trichomoniasis. The single-use kit from Visby Medical ...
MarketWatch

Visby Medical Receives Landmark FDA De Novo Authorization for First-Ever OTC PCR Test for Sexual Health

SAN JOSE, Calif., March 28, 2025 /PRNewswire/ -- Today, Visby Medical(TM), a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo ...