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 862.1065](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1065) → JIE — Method, Ion-Exchange, Ammonia

# JIE · Method, Ion-Exchange, Ammonia

_Clinical Chemistry · 21 CFR 862.1065 · Class 1_

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

## Overview

- **Product Code:** JIE
- **Device Name:** Method, Ion-Exchange, Ammonia
- **Regulation:** [21 CFR 862.1065](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1065)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

## Classification Rationale

Class I.

## 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/JIE](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIE)

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