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Self-Contained, Rapid ADEXUSDx® COVID-19 Antibody Test Receives CE Mark americanpharmaceuticalreview
August 04, 2020
NOWDiagnostics has received Conformité Européene (CE) mark approval for its ADEXUSDx® COVID-19 antibody test for use in moderate/complex laboratory settings across 28 countries in the European Union (EU).
COVID-19 rapid antibody tests approved for use in UK europeanpharmaceuticalreview
July 31, 2020
Abingdon Health’s COVID-19 rapid antibody test has been registered with the UK’s Medicines and Healthcare products Regulatory Agency.
Virality Diagnostics Antibody Test Wins FDA EUA americanpharmaceuticalreview
July 03, 2020
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test distributed by Virality Diagnostics, manufactured by Biohit (Hefei).
Truvian Sciences Introduces Easy Check COVID-19 IgM/IgG Test americanpharmaceuticalreview
June 30, 2020
Truvian Sciences has introduced Easy Check COVID-19 IgM/IgG, a rapid, highly accurate and scalable COVID-19 antibody test.
Roche not yet meeting demand for molecular COVID-19 tests, chairman says expresspharma
June 30, 2020
Demand for its antibody tests, which determine whether people have ever been infected with the coronavirus, can be met as Roche has been boosting production, he said.
Biomerica Files for EUA for its COVID-19 Laboratory Antibody Test americanpharmaceuticalreview
June 29, 2020
Biomerica submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for an ELISA lab-based serology blood test for the detection of antibodies that identify if a person has been infected with ...
FDA Revokes Emergency Use Authorization for Chembio Antibody Test americanpharmaceuticalreview
June 29, 2020
The U.S. Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) of the Chembio Diagnostic System DPP COVID-19 IgM/IgG System ...
Vivera Files First of Two US Made COVID-19 Antibody Tests americanpharmaceuticalreview
June 22, 2020
Vivera Pharmaceuticals has announced the launch of their point-of-care ready rapid serology tests.
FDA Publicly Shares Antibody Test Performance Data from Kits as Part of Validation Study americanpharmaceuticalreview
June 16, 2020
The U.S. Food and Drug Administration (FDA) publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) ...
Parkway Clinical Laboratories Launches COVID-19 Immune Response Consumer Direct Access Testing prnewswire
June 16, 2020
Parkway Clinical Laboratories Inc. (PCL), announced it has launched COVID-19 Immune Response Serum Immunoglobin IGG Antibody test available directly to consumers.

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