AGGLUTINOTEST-PERTUSSIS
Device Facts
| Record ID | K791454 |
|---|---|
| Device Name | AGGLUTINOTEST-PERTUSSIS |
| Applicant | Volu Sol Medical Industries |
| Product Code | GOX · Microbiology |
| Decision Date | Sep 24, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3065 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Bordetella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, used in serological tests to identify Bordetella spp. from cultured isolates or directly from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Bordetella and provides epidemiological information on these diseases. Bordetella spp. cause whooping cough (Bordetella pertussis) and other similiarly contagious and acute respiratory infections characterized by pneumonitis (inflammation of the lungs).
