Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3400](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3400) → GQR — Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4

# GQR · Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4

_Microbiology · 21 CFR 866.3400 · Class 1_

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

## Overview

- **Product Code:** GQR
- **Device Name:** Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4
- **Regulation:** [21 CFR 866.3400](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3400)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to 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 the limitations in § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K812365](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQR/K812365.md) | PARA 1 SENDAI HEMAGGLUTININ | Dutchland Laboratories, Inc. | Sep 9, 1981 | SESE |

## Top Applicants

- Dutchland Laboratories, Inc. — 1 clearance

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

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