Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7375](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7375) → GII — Glutathione, Red-Cell

# GII · Glutathione, Red-Cell

_Hematology · 21 CFR 864.7375 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GII

## Overview

- **Product Code:** GII
- **Device Name:** Glutathione, Red-Cell
- **Regulation:** [21 CFR 864.7375](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7375)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A glutathione reductase assay is a device used to determine the activity of the enzyme glutathione reductase in serum, plasma, or erythrocytes by such techniques as fluorescence and photometry. The results of this assay are used in the diagnosis of liver disease, glutathione reductase deficiency, or riboflavin deficiency.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GII](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GII)

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