Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3380](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3380) → GRA — Antiserum, Fluorescent, Mumps Virus

# GRA · Antiserum, Fluorescent, Mumps Virus

_Microbiology · 21 CFR 866.3380 · Class 1_

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

## Overview

- **Product Code:** GRA
- **Device Name:** Antiserum, Fluorescent, Mumps Virus
- **Regulation:** [21 CFR 866.3380](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3380)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K894624](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GRA/K894624.md) | MUMPS VIRUS | Bion Ent., Ltd. | Oct 16, 1989 | SESE |
| [K822826](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GRA/K822826.md) | ANTIBODY TO MUMPS VIRUS IFA TEST | Electro-Nucleonics Laboratories, Inc. | Dec 3, 1982 | SESE |
| [K770216](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GRA/K770216.md) | VIRAL ANTISERA, FLUORESCEIN LABELED | Flow Laboratories, Inc. | Mar 1, 1977 | SESE |

## Top Applicants

- Bion Ent., Ltd. — 1 clearance
- Electro-Nucleonics Laboratories, Inc. — 1 clearance
- Flow Laboratories, Inc. — 1 clearance

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

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