← Product Code [JIF](/productcode/JIF) · K880651

# PARAMAX AMMONIA REAGENT (K880651)

_Baxter Healthcare Corp · JIF · Mar 24, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K880651

## Device Facts

- **Applicant:** Baxter Healthcare Corp
- **Product Code:** [JIF](/productcode/JIF.md)
- **Decision Date:** Mar 24, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1065
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda-staging.innolitics.com/device/K880651](https://fda-staging.innolitics.com/device/K880651)

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