21 CFR 866.3370
§ 866.3370
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 866.3370, § 866.3370, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89535
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.