§ 862.1225. Creatinine test system.
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/us/cfr/t21/s§ 862.1225·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
(b)Classification. Class II.