← Product Code [JTY](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTY) · K950196

# CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (K950196)

_Bioclinical Systems, Inc. · JTY · Jun 30, 1995 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTY/K950196

## Device Facts

- **Applicant:** Bioclinical Systems, Inc.
- **Product Code:** [JTY](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTY.md)
- **Decision Date:** Jun 30, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2410
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

A culture medium for pathogenic Neisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenic Neisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTY/K950196](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTY/K950196)

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