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) → JRY — Antiserum, Fluorescent, Epstein-Barr Virus

# JRY · Antiserum, Fluorescent, Epstein-Barr Virus

_Microbiology · 21 CFR 866.3235 · Class 1_

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

## Overview

- **Product Code:** JRY
- **Device Name:** Antiserum, Fluorescent, Epstein-Barr Virus
- **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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K042118](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K042118.md) | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM | Zeus Scientific, Inc. | Apr 29, 2005 | SESE |
| [K900974](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K900974.md) | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | Stellar Bio Systems, Inc. | Apr 16, 1990 | SESE |
| [K891785](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K891785.md) | BION EBV-G (VCA) TEST SYSTEM | Bion Ent., Ltd. | Aug 31, 1989 | SESE |
| [K884829](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K884829.md) | EBV EARLY ANTIGEN (R+D) | Hillcrest Biologicals | Apr 12, 1989 | SESE |
| [K822734](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K822734.md) | EBV IGM TEST | Gull Laboratories, Inc. | Dec 9, 1982 | SESE |
| [K822985](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K822985.md) | EBV-M KIT | Litton Bionetics | Dec 3, 1982 | SESE |
| [K821849](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K821849.md) | EBV-VCA ANTIBODY ASSAY KIT | Biotech Research Laboratories, Inc. | Aug 12, 1982 | SESE |
| [K811262](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K811262.md) | EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI | Zeus Scientific, Inc. | May 27, 1981 | SESE |
| [K780925](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/JRY/K780925.md) | EB-VCA, TEST, ANTIBODY, FLUORESCENT | Litton Bionetics | Jun 22, 1978 | SESE |

## Top Applicants

- Litton Bionetics — 2 clearances
- Zeus Scientific, Inc. — 2 clearances
- Bion Ent., Ltd. — 1 clearance
- Biotech Research Laboratories, Inc. — 1 clearance
- Gull Laboratories, Inc. — 1 clearance

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

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