- new product
Healgen Scientific Receives FDA De Novo Marketing Authorization for At-Home COVID-19 and Influenza Test
HOUSTON, Oct. 8, 2024 /PRNewswire/ -- Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA's De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique...
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