Some Chinese-made COVID-19 antibody tests being used in the U.S. were not approved by China's FDA. China has now barred their export.
the study will show how deadly the coronavirus is and the effectiveness of strategies such as social distancing and wearing masks.
Josh Disbrow, chief executive of Aytu, confirmed to NBC News by phone that Zhejiang Orient's tests have not been approved by the NMPA. He emphasized that the tests have been validated in a study by third-party clinical researchers.While that study showed a satisfactory performance of the test, the researchers said their findings were limited and that results for the Zhejiang Orient tests needed to be compared with results from other antibody tests to gauge performance.
Responding to an email requesting information about the antibody test it has supplied to Premier, Hangzhou said via an automated response on Wednesday,"We are sorry to inform you, according to the latest regulatory policy requirements from government, we suspended the export sales of the COVID-19 IgG/IgM Rapid Test."
Export records show that on April 10, Healgen received two shipments from its parent Zhejiang Orient in
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