§ 866.3370. Mycobacterium tuberculosis immunofluorescent reagents.
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/us/cfr/t21/s§ 866.3370·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. Mycobacterium tuberculosis immunofluorescent reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Mycobacterium tuberculosis directly from clinical specimens. The identification aids in the diagnosis of tuberculosis and provides epidemiological information on this disease. Mycobacterium tuberculosis is the common causative organism in human tuberculosis, a chronic infectious disease characterized by formation of tubercles (small rounded nodules) and tissue necrosis (destruction), usually occurring in the lung.
(b)Classification. Class I (general controls).