21 CFR § 866.3370 - immunofluorescent reagents.

---
identifier: "/us/cfr/t21/s866.3370"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3370 - immunofluorescent reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3370"
section_name: "immunofluorescent reagents."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 866.3370 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).