Roche Professional Diagnostics
Country not established
- Devices
- 2
What Roche Professional Diagnostics makes
Roche Professional Diagnostics manufactures in vitro diagnostic assays, including the ANTI-HAV test for detecting antibodies to hepatitis A virus and the Elecsys CA-125 II assay for measuring cancer antigen 125 levels in serum or plasma.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Anti-Hav Ref K100903
Regimes: 510(k) Registry: 510(k)Elecsys CA-125 II assay Ref K143534
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Roche Professional Diagnostics have in the registry?
The registry currently lists 2 devices for Roche Professional Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roche Professional Diagnostics's devices?
Among its 2 most recently registered devices, Roche Professional Diagnostics has devices listed in FDA 510(k) (2 devices).
What risk classes do Roche Professional Diagnostics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Roche Professional Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roche Professional Diagnostics in the registry?
The most recently registered devices listed for Roche Professional Diagnostics include ANTI-HAV and Elecsys CA-125 II assay.