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) → KIW — Kit, Mycoplasma Detection

# KIW · Kit, 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/KIW

## Overview

- **Product Code:** KIW
- **Device Name:** Kit, 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K860695](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIW/K860695.md) | GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) | Gibco Laboratories Life Technologies, Inc. | Mar 12, 1986 | SESE |
| [K851275](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIW/K851275.md) | GIBCO MYCOTECT 189-5670 | Gibco Laboratories Life Technologies, Inc. | Jun 21, 1985 | SESE |

## Top Applicants

- Gibco Laboratories Life Technologies, Inc. — 2 clearances

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

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