Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3870](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3870) → OUZ — Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

# OUZ · Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

_Microbiology · 21 CFR 866.3870 · Class 1_

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

## Overview

- **Product Code:** OUZ
- **Device Name:** Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
- **Regulation:** [21 CFR 866.3870](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3870)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Trypanosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Trypanosoma spp. in serum. The identification aids in the diagnosis of trypanosomiasis, a disease caused by parasitic protozoans belonging to the genus Trypanosoma. Trypanosomiasis in adults is a chronic disease characterized by fever, chills, headache, and vomiting. Central nervous system involvement produces typical sleeping sickness syndrome: physical exhaustion, inability to eat, tissue wasting, and eventual death. Chagas disease, an acute form of trypanosomiasis in children, most seriously affects the central nervous system and heart muscle.

## Classification Rationale

Class I (general controls).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K081868](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OUZ/K081868.md) | SMART LEISH, MODEL LGM1-050 | U.S. Army Medical Research Institute of Infectious | May 25, 2011 | SESE |

## Top Applicants

- U.S. Army Medical Research Institute of Infectious — 1 clearance

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

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