Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2350](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2350) → JRZ — Media, Culture, Amino Acid Assay

# JRZ · Media, Culture, Amino Acid Assay

_Microbiology · 21 CFR 866.2350 · Class 1_

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

## Overview

- **Product Code:** JRZ
- **Device Name:** Media, Culture, Amino Acid Assay
- **Regulation:** [21 CFR 866.2350](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2350)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

## 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 § 866.9.

## 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/JRZ](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JRZ)

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