BINAX LEGIONELLA URINARY ANTIGEN EIA
Device Facts
| Record ID | K934965 |
|---|---|
| Device Name | BINAX LEGIONELLA URINARY ANTIGEN EIA |
| Applicant | Binax, Inc. |
| Product Code | MJH · Microbiology |
| Decision Date | Sep 20, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3300 |
| Device Class | Class 2 |
Regulatory Classification
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).
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.
