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) → MIU — Enzyme Linked Immunosorbent Assay, T. Cruzi

# MIU · Enzyme Linked Immunosorbent Assay, T. Cruzi

_Microbiology · 21 CFR 866.3870 · Class 1_

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

## Overview

- **Product Code:** MIU
- **Device Name:** Enzyme Linked Immunosorbent Assay, T. Cruzi
- **Regulation:** [21 CFR 866.3870](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3870)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K161947](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIU/K161947.md) | Chagas Detect Plus Rapid Test | InBios International, Inc. | Dec 16, 2016 | SESE |
| [K072732](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIU/K072732.md) | ORTHO T. CRUZI ELISA TEST SYSTEM | Ortho-Clinical Diagnostics, Inc. | Apr 15, 2009 | SESE |
| [K023889](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIU/K023889.md) | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | Wiener Laboratories Saic | Feb 11, 2004 | SESE |
| [K930272](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIU/K930272.md) | HEMAGEN CHAGAS' KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | May 19, 1995 | SESE |
| [K933716](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIU/K933716.md) | ABBOTT CHAGAS ANTIBODY EIA | Abbott Laboratories | Dec 19, 1994 | SESE |
| [K911233](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIU/K911233.md) | CHAGAS' IGG ELISA TEST | Gull Laboratories, Inc. | May 4, 1992 | SESE |

## Top Applicants

- Abbott Laboratories — 1 clearance
- Gull Laboratories, Inc. — 1 clearance
- Hemagen Diagnostics, Inc. — 1 clearance
- InBios International, Inc. — 1 clearance
- Ortho-Clinical Diagnostics, Inc. — 1 clearance

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

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