{"data":{"id":"us/21-cfr-866.5640","jurisdiction":"us","citation":"21 CFR 866.5640","heading":"Infectious mononucleosis immunological test system.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES","Subpart F—Immunological Test Systems"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"ac58882ed3e365554a6836a48ae568d64ae0cf6d2beb029d24edc0615e0ffcf5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5630","next":"us/21-cfr-866.5660"},"notice":"GroundRules: Original legal text. Not legal advice."}