In Warning Letter, FDA Says ParagonDx ASR Probes for Warfarin Sensitivity Require Premarket Approval

According to the agency, ParagonDx's ASR probes for gauging the presence of CYP2C9*2, CYP2C9*3, VKORC1 1173, VKORC1 3730 variants "are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body."

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