Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2560](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2560) → MZC — System, Detection, Bacterial, For Platelet Transfusion Products

# MZC · System, Detection, Bacterial, For Platelet Transfusion Products

_Microbiology · 21 CFR 866.2560 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MZC

## Overview

- **Product Code:** MZC
- **Device Name:** System, Detection, Bacterial, For Platelet Transfusion Products
- **Regulation:** [21 CFR 866.2560](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2560)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

## Classification Rationale

Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MZC](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MZC)

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