Yahoo

FDA authorizes over-the-counter combined COVID-19 and flu test

The Food and Drug Administration is making it easier for people to simultaneously test themselves for COVID-19 and the flu at home. The agency this week authorized the Healgen Scientific's Rapid Check ...
Morningstar

Healgen Scientific Spotlights the Rapid Check® COVID-19/Flu A&B Antigen Test to Help Families Stay Prepared for the Respiratory Virus Season

HOUSTON, Nov. 26, 2025 /PRNewswire/ -- As the holiday season approaches, gatherings among family and friends are expected to increase the risk of respiratory virus transmission, including COVID-19 and ...
Yahoo

FDA approves the first at-home test for COVID-19 and the flu, no prescription needed

The Food and Drug Administration has granted authorization of a COVID-19 and flu test that can be used without a prescription. The authorization, announced Monday, uses a nasal swab to detect the ...
Monthly Prescribing Reference

FDA Grants De Novo Authorization to At-Home COVID-19/Flu Test

Credit: Healgen Scientific. The Healgen at-home test is the first OTC test for influenza detection to be granted marketing authorization outside of an emergency use authorization. The Food and Drug ...
abc27

Healgen's At-Home COVID-19 and Influenza Test Achieves FDA De Novo Status with Key Support from CovarsaDx® Research Team

LOS ANGELES, Oct. 9, 2024 /PRNewswire/ -- CovarsaDx ®, a prominent Clinical Research Organization (CRO) renowned for its expertise in vitro diagnostics (IVDs) and medical devices, proudly announced ...
PR Newswire

Healgen Scientific Receives FDA De Novo Marketing Authorization for At-Home COVID-19 and Influenza Test

Healgen Rapid Check® COVID-19/Flu A&B Antigen Test was supported through the Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) ...