CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES > SUBPART F—Immunological Test Systems (§866.5040 to §866.5910) > 866.5640—Infectious mononucleosis immunological test system.

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).

Code of Federal Regulations

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