LQH · Dna-Reagents, Legionella
Microbiology · 21 CFR 866.3300 · Class 2
Overview
| Product Code | LQH |
|---|---|
| Device Name | Dna-Reagents, Legionella |
| Regulation | 21 CFR 866.3300 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identify Haemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Haemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033861 | BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | Mar 9, 2004 | SESE |
| K860498 | GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM | Gen-Probe, Inc. | Jul 16, 1986 | SESE |
Top Applicants
- Becton, Dickinson & CO — 1 clearance
- Gen-Probe, Inc. — 1 clearance
