Finding studies
Finding studies
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Lead
Hikari Dx, Inc.
With
This study will compare PL assay measurements obtained with the T-TAS wS instrument (subject device) with PL assay measurements obtained with the T-TAS 01 instrument (predicate method). The T-TAS PL assay will be used to facilitate the comparison between instruments using intended use blood samples from the intended use population. The study will be conducted at a minimum of 3 locations in the United States and will enroll up to 120 subjects. The following subject populations will be enrolled into the study (minimum enrollment numbers indicated in parentheses): * Ostensibly healthy subjects * Subjects taking 81 mg or higher daily aspirin monotherapy (ASA) * Subjects taking dual antiplatelet therapy (DAPT) * Subjects with von Willebrand disease (VWD)
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
