Sierra Diagnostics
Country not established
- Devices
- 1
What Sierra Diagnostics makes
Sierra Diagnostics manufactures the GONOSTAT gonococcal detection kit, a diagnostic test designed to identify *Neisseria gonorrhoeae* infections in clinical samples.
The company’s portfolio is regulated under FDA’s Class II device classification, with the GONOSTAT kit authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Gonostat Gonococcal Detection Kit Ref K991268
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sierra Diagnostics have in the registry?
The registry currently lists 1 device for Sierra Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sierra Diagnostics's devices?
Among its 1 most recently registered device, Sierra Diagnostics has devices listed in FDA 510(k) (1 device).
What risk classes do Sierra Diagnostics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Sierra Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sierra Diagnostics in the registry?
The most recently registered devices listed for Sierra Diagnostics include GONOSTAT GONOCOCCAL DETECTION KIT.