Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3480](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3480) → MCE — Respiratory Syncytial Virus - Elisa

# MCE · Respiratory Syncytial Virus - Elisa

_Microbiology · 21 CFR 866.3480 · Class 1_

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

## Overview

- **Product Code:** MCE
- **Device Name:** Respiratory Syncytial Virus - Elisa
- **Regulation:** [21 CFR 866.3480](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3480)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.

## 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 |
| --- | --- | --- | --- | --- |
| [K061008](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCE/K061008.md) | QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 | Quidel Corp. | Sep 8, 2006 | SESE |
| [K924289](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCE/K924289.md) | KALLESTAD RSV MICROPLATE EIA | Bio-Rad Laboratories, Inc. | Feb 12, 1993 | SESE |

## Top Applicants

- Quidel Corp. — 1 clearance
- Bio-Rad Laboratories, Inc. — 1 clearance

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

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