21 CFR 866.3235 — Antiserum, Cf, Epstein-Barr Virus
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3235
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 | 20 | 3rd Party |
| GNQ | Antigen, Cf (Including Cf Control), Epstein-Barr Virus | 1 | 0 | 3rd Party |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 1 | 9 | 3rd Party |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | 23 | 3rd Party |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 | 27 | 3rd Party |
| LSE | Epstein-Barr Virus, Other | 1 | 56 | 3rd Party |
| LSF | Dna-Reagents, Epstein-Barr Virus | 1 | 0 | 3rd Party |
| MCD | Antigen, Ebv, Capsid | 1 | 8 | 3rd Party |
