Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1490](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1490) → JMQ — M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)

# JMQ · M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)

_Clinical Chemistry · 21 CFR 862.1490 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMQ

## Overview

- **Product Code:** JMQ
- **Device Name:** M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)
- **Regulation:** [21 CFR 862.1490](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1490)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A lysozyme (muramidase) test system is a device intended to measure the activity of the bacteriolytic enzyme lysozyme (muramidase) in serum, plasma, leukocytes, and urine. Lysozyme measurements are used in the diagnosis and treatment of monocytic leukemia and kidney disease.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMQ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMQ)

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