Creatinine test system.

21 C.F.R. § 862.1225
in effectEffective: 2024-07-01
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(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.

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