Celera Diagnostics
Country not established
- Devices
- 1
What Celera Diagnostics makes
Celera Diagnostics produces a cystic fibrosis genotyping assay (Model 6L20-01), designed for genetic testing to identify mutations associated with the condition.
The assay is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Cystic Fibrosis Genotyping Assay, Model 6L20-01 Ref K062028
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Celera Diagnostics have in the registry?
The registry currently lists 1 device for Celera Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Celera Diagnostics's devices?
Among its 1 most recently registered device, Celera Diagnostics has devices listed in FDA 510(k) (1 device).
What risk classes do Celera Diagnostics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Celera Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Celera Diagnostics in the registry?
The most recently registered devices listed for Celera Diagnostics include CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01.