← Product Code [GQS](/submissions/MI/subpart-d%E2%80%94serological-reagents/GQS) · K905385

# P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905385)

_Virion (U.S.), Inc. · GQS · Mar 21, 1991 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQS/K905385

## Device Facts

- **Applicant:** Virion (U.S.), Inc.
- **Product Code:** [GQS](/submissions/MI/subpart-d%E2%80%94serological-reagents/GQS.md)
- **Decision Date:** Mar 21, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3400
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQS/K905385](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQS/K905385)

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