EXTON, PA, May 24, 2021 – Megna Health, a U.S. manufacturer of Rapid COVID Tests based in Exton, Pennsylvania, announced that it has filed a U.S. Food and Drug Administration (FDA) EUA (Emergency Use Authorization) extension for Prescription Home Use for its Rapid COVID-19 IgG/IgM Antibody Test and is preparing Read more…
EXTON, PA. (PRWEB) APRIL 23, 2021 Megna Health announced today that its Rapid COVID-19 IgM/IgG Test, previously authorized for use under the U.S. Food and Drug Administration (FDA) Emergency Use Authorization, is now available for Point of Care Settings. The test can now be administered in CLIA-waived settings using fingerstick whole Read more…
EXTON, PA. September 28, 2020. Megna Health, a medical technology company based in Exton, PA, announced today that its Rapid COVID-19 Antigen Kit has been CE certified for European market. Megna Health’s Rapid COVID-19 Antigen Test detects is a lateral flow immunoassay intended for rapid qualitative detection of nucleocapsid antigens Read more…
Exton, PA, September 2, 2020. Megna Health, a medical technology company, announced today that its Rapid COVID-19 IgG and IgM Antibody Test has been CE certified for European market. CE certification (CE Mark) is the approval process of marketing medical and diagnostic products within the European Union. For more information, Read more…
Megna Health, a medical technology company focused on the development and manufacturing of diagnostic and healthcare products, announced today that the Company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Rapid COVID-19 IgG and IgM Combo Test Kit. Serology testing for COVID-19 Read more…
Exton, PA, July 13, 2020 Megna Health, a medical technology company based in Exton, PA, announces results from independent validation of its Rapid COVID-19 Antibody IgG / IgM Test by NIH / NCI (National Cancer Institute) coordinated by FDA. Results show sensitivity of 100% for IgG, and IgG /IgM combined; Read more…