Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3360](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3360) → GQJ — Antiserum, Cf, Lymphocytic Choriomeningitis Virus

# GQJ · Antiserum, Cf, Lymphocytic Choriomeningitis Virus

_Microbiology · 21 CFR 866.3360 · Class 1_

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

## Overview

- **Product Code:** GQJ
- **Device Name:** Antiserum, Cf, Lymphocytic Choriomeningitis Virus
- **Regulation:** [21 CFR 866.3360](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3360)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Lymphocytic choriomeningitis virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to lymphocytic choriomeningitis virus in serum. The identification aids in the diagnosis of lymphocytic choriomeningitis virus infections and provides epidemiological information on diseases caused by these viruses. Lymphocytic choriomeningitis viruses usually cause a mild cerebral meningitis (inflammation of membranes that envelop the brain) and occasionally a mild pneumonia, but in rare instances may produce severe and even fatal illnesses due to complications from cerebral meningitis and pneumonia.

## 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 (0 of 0)

_No cleared devices on record._

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

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