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FDA granted De Novo classification for VasQ TM on September 26, 2023, for the same indication as the one covered by the Breakthrough Device designation

doi: 10.1016/j.neuro.2019.11.009 146 XieL.ZhuQ.ZhangG.YeK.ZouC.PrezhdoO

Zheng Z, Humphrey CW, King RS, Richard JL (2005) Validation of an ELISA test kit for the detection of total aflatoxins in grain and grain products by comparison with HPLC