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emergency use authorization approved

Kantaro Gets FDA Authorization for COVID-19 Antibody Test

December 1, 2020

Kantaro Biosciences has received the FDA’s Emergency Use Authorization for COVID-SeroKlir, a semi-quantitative coronavirus antibody test kit.

The SeroKlir test kit, which previously received CE mark certification, is designed to be used in clinical settings to detect the presence or absence of COVID-19 antibodies and their levels. It does not require any proprietary equipment, according to the company.

Kantaro said it is currently working with Bio-Techne, a biotechnology product manufacturer, to make up to 10 million tests per month and that capacity could increase in the future.

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