21 CFR § 866.3235 - Epstein-Barr virus serological reagents.

---
identifier: "/us/cfr/t21/s866.3235"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3235 - Epstein-Barr virus serological reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3235"
section_name: "Epstein-Barr virus serological reagents."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 866.3235 Epstein-Barr virus serological reagents.

(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).