GOX · Antigen, B. Pertussis
Microbiology · 21 CFR 866.3065 · Class 1
Overview
| Product Code | GOX |
|---|---|
| Device Name | Antigen, B. Pertussis |
| Regulation | 21 CFR 866.3065 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K791454 | AGGLUTINOTEST-PERTUSSIS | Volu Sol Medical Industries | Sep 24, 1979 | SESE |
Top Applicants
- Volu Sol Medical Industries — 1 clearance
