Regulatory Text
21 C.F.R. § 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). [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982]
Source: ecfr.gov · govinfo.gov — public domain
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21 C.F.R. § 866.5640
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The regulatory text of 21 C.F.R. § 866.5640 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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