21 CFR § 866.5640 - Infectious mononucleosis immunological test system.

---
identifier: "/us/cfr/t21/s866.5640"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5640 - Infectious mononucleosis immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5640"
section_name: "Infectious mononucleosis immunological test system."
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"
---


# 866.5640 Infectious mononucleosis immunological test system.

(a) *Identification.* An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

(b) *Classification.* Class II (performance standards).

[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982]