Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3235](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3235) → MCD — Antigen, Ebv, Capsid

# MCD · Antigen, Ebv, Capsid

_Microbiology · 21 CFR 866.3235 · Class 1_

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

## Overview

- **Product Code:** MCD
- **Device Name:** Antigen, Ebv, Capsid
- **Regulation:** [21 CFR 866.3235](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3235)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

## Classification Rationale

Class I (general controls).

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K984126](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCD/K984126.md) | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | Jan 11, 1999 | SESE |
| [K933251](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCD/K933251.md) | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST | Virion (U.S.), Inc. | Jun 13, 1994 | SESE |
| [K925689](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCD/K925689.md) | MERIDIAN EBV-IGG TEST KIT | Fuller Laboratories, Inc. | Oct 12, 1993 | SESE |
| [K924091](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCD/K924091.md) | EBV-VCA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jan 11, 1993 | SESE |
| [K920412](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCD/K920412.md) | MODIFIED ORTHO EBV VCA-IGG ELISA | Ortho Diagnostic Systems, Inc. | Jun 22, 1992 | SESE |
| [K911571](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCD/K911571.md) | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | Jun 10, 1991 | SESE |
| [K911570](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCD/K911570.md) | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | Jun 10, 1991 | SESE |
| [K910872](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MCD/K910872.md) | EBV IGG ELISA TEST | Gull Laboratories, Inc. | Apr 12, 1991 | SESE |

## Top Applicants

- Ortho Diagnostic Systems, Inc. — 3 clearances
- Zeus Scientific, Inc. — 2 clearances
- Fuller Laboratories, Inc. — 1 clearance
- Gull Laboratories, Inc. — 1 clearance
- Virion (U.S.), Inc. — 1 clearance

---

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

**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