Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8625](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8625) → MZG — Test, Residual, Wbc In Leukoreduced Blood

# MZG · Test, Residual, Wbc In Leukoreduced Blood

_Hematology · 21 CFR 864.8625 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/MZG

## Overview

- **Product Code:** MZG
- **Device Name:** Test, Residual, Wbc In Leukoreduced Blood
- **Regulation:** [21 CFR 864.8625](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8625)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

## Classification Rationale

Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/MZG](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/MZG)

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