Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3600](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3600) → GNH — Antigen, Fluorescent Antibody Test, Schistosoma Mansoni

# GNH · Antigen, Fluorescent Antibody Test, Schistosoma Mansoni

_Microbiology · 21 CFR 866.3600 · Class 1_

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

## Overview

- **Product Code:** GNH
- **Device Name:** Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
- **Regulation:** [21 CFR 866.3600](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3600)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Schistosoma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Schistosoma spp. in serum. The identification aids in the diagnosis of schistosomiasis caused by parasitic flatworms of the genus Schistosoma. Schistosomiasis is characterized by a variety of acute and chronic infections. Acute infection is marked by fever, allergic symptoms, and diarrhea. Chronic effects are usually severe and are caused by fibrous degeneration of tissue around deposited eggs of the parasite in the liver, lungs, and central nervous system. Schistosomes can also cause schistosome dermatitis (e.g., swimmer's itch), a skin disease marked by intense itching.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K842660](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNH/K842660.md) | ANTI-SCHISTOSOMA SPECIES KIT | Amico Lab, Inc. | Oct 30, 1984 | SESE |
| [K842527](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNH/K842527.md) | AMIZYME-SCHISTOSOMA SPP. TEST KIT | Amico Lab, Inc. | Sep 5, 1984 | SESE |

## Top Applicants

- Amico Lab, Inc. — 2 clearances

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

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