← Product Code [GQQ](/submissions/MI/subpart-d%E2%80%94serological-reagents/GQQ) · K780007

# GOAT ANTI-INFLUENZA ANTISERA (K780007)

_Northeast Biomedical Labs., Inc. · GQQ · Jan 20, 1978 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQQ/K780007

## Device Facts

- **Applicant:** Northeast Biomedical Labs., Inc.
- **Product Code:** [GQQ](/submissions/MI/subpart-d%E2%80%94serological-reagents/GQQ.md)
- **Decision Date:** Jan 20, 1978
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQQ/K780007](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQQ/K780007)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
