Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1225](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1225) → NFZ — Test, Creatinine, Over The Counter

# NFZ · Test, Creatinine, Over The Counter

_Clinical Chemistry · 21 CFR 862.1225 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NFZ

## Overview

- **Product Code:** NFZ
- **Device Name:** Test, Creatinine, Over The Counter
- **Regulation:** [21 CFR 862.1225](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1225)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NFZ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NFZ)

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