INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
Device Facts
| Record ID | K946158 |
|---|---|
| Device Name | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT |
| Applicant | Incstar Corp. |
| Product Code | LLM · Microbiology |
| Decision Date | Jun 9, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3235 |
| Device Class | Class 1 |
Regulatory Classification
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).
