NJO · System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
Microbiology · 21 CFR 866.3370 · Class 1
Overview
| Product Code | NJO |
|---|---|
| Device Name | System, Mycolic Acid Analysis, 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 |
|---|---|---|---|---|
| K020689 | SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM | Midi, Inc. | Oct 31, 2002 | SESE |
Top Applicants
- Midi, Inc. — 1 clearance
