Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
Subpart B - Clinical Chemistry Test Systems |
§ 862.1225 - Creatinine test system.
Latest version.
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§ 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.