ThermoGenesis Receives Acknowledgement Letter from FDA Allowing Its SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit for Distribution
ThermoGenesis Holdings, Inc. (THMO)
Last thermogenesis holdings, inc. earnings: 11/19 04:05 pm
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Source: PR Newswire
RANCHO CORDOVA, Calif., April 16, 2020 /PRNewswire/ -- ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, announced today that on Wednesday April 15th, following submission of notification to the U.S. Food and Drug Administration (FDA), the Company has received the necessary acknowledgement letter which provided confirmation that the ThermoGenesis' SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit has been appropriately validated in accordance with Section IV.D. of the "Policy for Diagnostic Tests for Coronavirus Disease - 2019 during the Public Health Emergency," issued by FDA on March 16, 2020. The required registrations and listings with FDA have been completed, which now allow the diagnostic kit to be distributed.An informational presentation on the COVID-19 Kit is available on the Company's website. The presentation is for educational purposes and will allow users to better under
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