# OJO · Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

_ ·  · Class N_

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

## Overview

- **Product Code:** OJO
- **Device Name:** Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## Identification

Enzyme linked immunosorbent assay (elisa) system intended for in vitro diagnostic use to qualitatively detect the presence of lipoarabinomannan (lam) antigen of mycobacteria in human urine as an aid in the diagnosis of current mycobacterial infection in hiv positive patients with systems of tuberculosis.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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