Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3205](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3205) → GRK — Antisera, Fluorescent, Echovirus 1-34

# GRK · Antisera, Fluorescent, Echovirus 1-34

_Microbiology · 21 CFR 866.3205 · Class 1_

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

## Overview

- **Product Code:** GRK
- **Device Name:** Antisera, Fluorescent, Echovirus 1-34
- **Regulation:** [21 CFR 866.3205](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3205)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Echovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to echovirus in serum. Additionally, some of these reagents consist of echovirus antisera conjugated with a fluorescent dye used to identify echoviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of echovirus infections and provides epidemiological information on diseases caused by these viruses. Echoviruses cause illnesses such as meningitis (inflammation of the brain and spinal cord membranes), febrile illnesses (accompanied by fever) with or without rash, and the common cold.

## 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 the limitations in § 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/GRK](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GRK)

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