21 C.F.R. § 862.1225

Current through October 31, 2024
Section 862.1225 - Creatinine test system
(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.

21 C.F.R. § 862.1225