← Product Code [KPB](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB) · K771867

# MYCOPLASMA DETECTION KIT (K771867)

_Bioassay Systems Research Corp. · KPB · Nov 17, 1977 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB/K771867

## Device Facts

- **Applicant:** Bioassay Systems Research Corp.
- **Product Code:** [KPB](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB.md)
- **Decision Date:** Nov 17, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.2360
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

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

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB/K771867](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KPB/K771867)

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