21 CFR 866.3370 — Antiserum, Fluorescent, Mycobacterium Tuberculosis
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3370
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.
Classification Rationale
Class I (general controls).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GRT | Antiserum, Fluorescent, Mycobacterium Tuberculosis | 1 | 1 | 3rd Party |
| LQF | Dna-Reagents, Mycobacterium Spp. | 1 | 15 | 3rd Party |
| NDZ | Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis | 1 | 1 | 3rd Party |
| NJO | System, Mycolic Acid Analysis, Mycobacterium Tuberculosis | 1 | 1 | 3rd Party |
