Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5680](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5680) → MVE — Biosensor, Immunoassay, Myoglobin

# MVE · Biosensor, Immunoassay, Myoglobin

_Immunology · 21 CFR 866.5680 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MVE

## Overview

- **Product Code:** MVE
- **Device Name:** Biosensor, Immunoassay, Myoglobin
- **Regulation:** [21 CFR 866.5680](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5680)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K981536](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MVE/K981536.md) | QUANTECH MYOGLOBIN ASSAY | Hellen Professional Services | Jun 29, 1998 | SESE |

## Top Applicants

- Hellen Professional Services — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MVE](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MVE)

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