21 CFR 862.1225 — Electrode, Ion Based, Enzymatic, Creatinine
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1225
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 2 | 7 | 3rd Party |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 159 | 3rd Party |
| JFY | Enzymatic Method, Creatinine | 2 | 49 | 3rd Party |
| NDY | Test, Cystatin C | 2 | 22 | 3rd Party |
| NFZ | Test, Creatinine, Over The Counter | 2 | 0 | |
| SHB | Creatinine Test System For At Home Prescription Use | 2 | 1 |
