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Megna Health Announces Submission of Application to the FDA for Emergency Use Authorization of its Rapid COVID-19 IgG & IgM Antibody Test for Prescription Home Use

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 for product launch.  The test […]

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Megna Health Receives Point of Care With Fingerstick, Emergency Use Authorization from the FDA for its Rapid COVID-19 IgM/IgG Combo Antibody Test

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 blood to detect COVID-19 antibodies.

Megna Health Receives Point of Care With Fingerstick, Emergency Use Authorization from the FDA for its Rapid COVID-19 IgM/IgG Combo Antibody Test Read More »

Megna Health Announces CE Certification of its Rapid COVID-19 Antigen Test

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 from COVID-19 in human nasal

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Megna Health Announces CE Certification of Its Rapid COVID-19 Antibody IgG / IgM Test

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, please contact info@megnahealth.com

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Megna Health Announces FDA Emergency Authorization of Rapid COVID-19 Antibody IgM/IgG Test Kit

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 is at an increased demand

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Megna Health Announces Independent Validation Results of Its Rapid COVID-19 Antibody IgG & IgM Test by NIH/NCI

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; Combined specificity of 95%. Click

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