Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart C — Cell And Tissue Culture Products](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products) → [21 CFR 864.2360](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/864.2360) → KIX — Media, Mycoplasma Detection

# KIX · Media, Mycoplasma Detection

_Hematology · 21 CFR 864.2360 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIX

## Overview

- **Product Code:** KIX
- **Device Name:** Media, Mycoplasma Detection
- **Regulation:** [21 CFR 864.2360](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/864.2360)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.

## Classification Rationale

Class I (general controls). These devices are 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._

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIX](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIX)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com