← Product Code [LFZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ) · K915892

# CMV IGG ELISA TEST (K915892)

_Gull Laboratories, Inc. · LFZ · Feb 14, 1992 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ/K915892

## Device Facts

- **Applicant:** Gull Laboratories, Inc.
- **Product Code:** [LFZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ.md)
- **Decision Date:** Feb 14, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3175
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ/K915892](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFZ/K915892)

**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