Creatinine test system.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Clinical Chemistry and Clinical Toxicology Devices
  7. Clinical Chemistry Test Systems
  8. Creatinine test system.

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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.


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