NDZ · Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Microbiology · 21 CFR 866.3370 · Class 1
Overview
| Product Code | NDZ |
|---|---|
| Device Name | Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis |
| Regulation | 21 CFR 866.3370 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000884 | BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY | Becton Dickinson Biosciences | Jan 19, 2001 | SESE |
Top Applicants
- Becton Dickinson Biosciences — 1 clearance
