← Product Code [LQF](/submissions/MI/subpart-d%E2%80%94serological-reagents/LQF) · K896492

# ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST (K896492)

_Gen-Probe, Inc. · LQF · Apr 16, 1990 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LQF/K896492

## Device Facts

- **Applicant:** Gen-Probe, Inc.
- **Product Code:** [LQF](/submissions/MI/subpart-d%E2%80%94serological-reagents/LQF.md)
- **Decision Date:** Apr 16, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3370
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Mycobacterium tuberculosis immunofluorescent reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Mycobacterium tuberculosis directly from clinical specimens. The identification aids in the diagnosis of tuberculosis and provides epidemiological information on this disease. Mycobacterium tuberculosis is the common causative organism in human tuberculosis, a chronic infectious disease characterized by formation of tubercles (small rounded nodules) and tissue necrosis (destruction), usually occurring in the lung.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LQF/K896492](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LQF/K896492)

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