21 CFR § 866.3235 Immunology and Microbiology Devices

§ 866.3235 Epstein-Barr virus serological reagents.

Current through Sep 8, 2026 · Read all of Part 866

⚠ 4 pending changes to Part 866

(a) 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).

(b) Classification. Class I (general controls).

← § 866.3231 Device to detect bacterial protease activity in chronic wound fluid.§ 866.3236 Device to detect or measure nucleic acid from viruses associated with head and neck cancers. →