Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7360](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7360) → JBI — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition

# JBI · Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition

_Hematology · 21 CFR 864.7360 · Class 2_

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

## Overview

- **Product Code:** JBI
- **Device Name:** Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition
- **Regulation:** [21 CFR 864.7360](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7360)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

## Classification Rationale

Class II (performance standards).

## 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/JBI](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBI)

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