LQF · Dna-Reagents, Mycobacterium Spp.
Microbiology · 21 CFR 866.3370 · Class 1
Overview
| Product Code | LQF |
|---|---|
| Device Name | Dna-Reagents, Mycobacterium Spp. |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K921435 | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE | Gen-Probe, Inc. | Jul 23, 1992 | SESE |
| K904463 | ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST | Gen-Probe, Inc. | Nov 13, 1990 | SESE |
| K897077 | ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE | Gen-Probe, Inc. | Aug 23, 1990 | SESE |
| K896494 | ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST | Gen-Probe, Inc. | Aug 23, 1990 | SESE |
| K897078 | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE | Gen-Probe, Inc. | May 2, 1990 | SESE |
| K896492 | ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST | Gen-Probe, Inc. | Apr 16, 1990 | SESE |
| K896493 | ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST | Gen-Probe, Inc. | Apr 11, 1990 | SESE |
| K900292 | SNAP M. TUBERCULOSIS COMPLEX | Syngene, Inc. | Apr 3, 1990 | SESE |
| K900202 | SNAP MYCOBACTERIA AVIUM COMPLEX | Syngene, Inc. | Apr 3, 1990 | SESE |
| K890089 | RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE | Gen-Probe, Inc. | Mar 13, 1989 | SESE |
| K871795 | RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. | Gen-Probe, Inc. | Jul 30, 1987 | SESE |
| K864597 | GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA | Gen-Probe, Inc. | Apr 20, 1987 | SESE |
| K862614 | RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX | Gen-Probe, Inc. | Nov 10, 1986 | SESE |
| K862613 | RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX | Gen-Probe, Inc. | Nov 10, 1986 | SESE |
| K860782 | GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM | Gen-Probe, Inc. | Jul 2, 1986 | SESE |
Top Applicants
- Gen-Probe, Inc. — 13 clearances
- Syngene, Inc. — 2 clearances
