← Product Code [KIW](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIW) · K860695

# GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) (K860695)

_Gibco Laboratories Life Technologies, Inc. · KIW · Mar 12, 1986 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIW/K860695

## Device Facts

- **Applicant:** Gibco Laboratories Life Technologies, Inc.
- **Product Code:** [KIW](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIW.md)
- **Decision Date:** Mar 12, 1986
- **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/KIW/K860695](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIW/K860695)

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