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Title 21 → Chapter I → Subchapter H → Part 866 → Subpart F → §866.5640 |
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§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]