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Warning: BrainCheck Assess is an FDA Class II Medical Device. The device should be interpreted only by qualified healthcare professionals. The device is not intended to be used as a stand-alone diagnostic device. The device is not intended to identify the presence or absence of clinical diagnosis. BrainCheck Screen, BrainCheck Plan and screeners are not regulated devices, but may be used alongside BrainCheck Assess to support clinical decision making in evaluating cognitive status.