BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
Device Facts
| Record ID | K000884 |
|---|---|
| Device Name | BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY |
| Applicant | Becton Dickinson Biosciences |
| Product Code | NDZ · Microbiology |
| Decision Date | Jan 19, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3370 |
| Device Class | Class 1 |
Regulatory Classification
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.
