← Product Code [KQE](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KQE) · K823900

# GLUCOSE-6-PHOSPHATE DEHYDROGENASE (K823900)

_Alladin Diagnostic, Inc. · KQE · Feb 7, 1983 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-h%E2%80%94hematology-kits-and-packages/KQE/K823900

## Device Facts

- **Applicant:** Alladin Diagnostic, Inc.
- **Product Code:** [KQE](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/KQE.md)
- **Decision Date:** Feb 7, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7360
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-h%E2%80%94hematology-kits-and-packages/KQE/K823900](https://fda.innolitics.com/submissions/TX/subpart-h%E2%80%94hematology-kits-and-packages/KQE/K823900)

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