← Product Code [JLM](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JLM) · K873625

# CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) (K873625)

_Boots-Celltech Diagnostics, Inc. · JLM · Oct 20, 1987 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-h%E2%80%94hematology-kits-and-packages/JLM/K873625

## Device Facts

- **Applicant:** Boots-Celltech Diagnostics, Inc.
- **Product Code:** [JLM](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JLM.md)
- **Decision Date:** Oct 20, 1987
- **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/CH/subpart-h%E2%80%94hematology-kits-and-packages/JLM/K873625](https://fda.innolitics.com/submissions/CH/subpart-h%E2%80%94hematology-kits-and-packages/JLM/K873625)

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