§ 866.5640. Infectious mononucleosis immunological test system.
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/us/cfr/t21/s§ 866.5640·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]