JRY · Antiserum, Fluorescent, Epstein-Barr Virus
Microbiology · 21 CFR 866.3235 · Class 1
Overview
| Product Code | JRY |
|---|---|
| Device Name | Antiserum, Fluorescent, Epstein-Barr Virus |
| Regulation | 21 CFR 866.3235 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 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 | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM | Zeus Scientific, Inc. | Apr 29, 2005 | SESE |
| K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | Stellar Bio Systems, Inc. | Apr 16, 1990 | SESE |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | Bion Ent., Ltd. | Aug 31, 1989 | SESE |
| K884829 | EBV EARLY ANTIGEN (R+D) | Hillcrest Biologicals | Apr 12, 1989 | SESE |
| K822734 | EBV IGM TEST | Gull Laboratories, Inc. | Dec 9, 1982 | SESE |
| K822985 | EBV-M KIT | Litton Bionetics | Dec 3, 1982 | SESE |
| K821849 | EBV-VCA ANTIBODY ASSAY KIT | Biotech Research Laboratories, Inc. | Aug 12, 1982 | SESE |
| K811262 | EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI | Zeus Scientific, Inc. | May 27, 1981 | SESE |
| K780925 | EB-VCA, TEST, ANTIBODY, FLUORESCENT | Litton Bionetics | Jun 22, 1978 | SESE |
Top Applicants
- Zeus Scientific, Inc. — 2 clearances
- Litton Bionetics — 2 clearances
- Stellar Bio Systems, Inc. — 1 clearance
- Hillcrest Biologicals — 1 clearance
- Gull Laboratories, Inc. — 1 clearance
