Title 21

SECTION 866.3370

866.3370 Mycobacterium tuberculosis immunofluorescent reagents.

§ 866.3370 Mycobacterium tuberculosis immunofluorescent reagents.

(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).

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