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) → KPB — Media And Components, Mycoplasma Detection

# KPB · Media And Components, 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/KPB

## Overview

- **Product Code:** KPB
- **Device Name:** Media And Components, 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K781875](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB/K781875.md) | STAIN KIT FOR CELL CULTURES (30-100-00) | Flow Laboratories, Inc. | Dec 20, 1978 | SESE |
| [K781874](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB/K781874.md) | MYCOPLASMA ARGININI FITC (30-403-41) | Flow Laboratories, Inc. | Dec 20, 1978 | SESE |
| [K781390](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB/K781390.md) | MYCOPLASMA HYORHINIS (BTS-7) | Flow Laboratories, Inc. | Sep 1, 1978 | SESE |
| [K771867](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB/K771867.md) | MYCOPLASMA DETECTION KIT | Bioassay Systems Research Corp. | Nov 17, 1977 | SESE |

## Top Applicants

- Flow Laboratories, Inc. — 3 clearances
- Bioassay Systems Research Corp. — 1 clearance

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

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