# OJN · Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/MI-misc/OJN

## Overview

- **Product Code:** OJN
- **Device Name:** Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P070006](https://fda.innolitics.com/submissions/MI/MI-misc/OJN/P070006.md) | T SPOT-TB TEST | Oxford Immunotec, Ltd. | Jul 30, 2008 | APPR |

## Top Applicants

- Oxford Immunotec, Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/MI-misc/OJN](https://fda.innolitics.com/submissions/MI/MI-misc/OJN)

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