Details
Device typeUric acid monitoring system IVD, home-use: A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of uric acid in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is used to monitor the effectiveness of uric acid control in various disorders (e.g., renal failure, gout, leukaemia), and in patients receiving cytotoxic chemotherapy.
FDA categoryAcid, Uric, Uricase (Oxygen Rate)
Device ID06935740727006
Single useYes
MRI safetyLabeling does not contain MRI Safety Information