Rochdiag
Country not established
- Devices
- 3
What Rochdiag makes
Rochdiag manufactures automated laboratory analyzers, including the COBAS INTEGRA C 111 system for biochemical testing, as well as calibrators and reagents like the TINA-QUANT Alpha-1 Antitrypsin assay and C.F.A.S. Lipids calibrator for automated systems.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These products are intended for use in clinical chemistry and lipid analysis. Rochdiag is based in the United States.
Catalogue
Cobas Integra C 111 Ref K063744
Regimes: 510(k) Registry: 510(k)Tina-Quant Alpha-1 Antitrypsin Ref K010978
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rochdiag have in the registry?
The registry currently lists 3 devices for Rochdiag. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rochdiag's devices?
Among its 3 most recently registered devices, Rochdiag has devices listed in FDA 510(k) (3 devices).
What risk classes do Rochdiag's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Rochdiag's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rochdiag in the registry?
The most recently registered devices listed for Rochdiag include COBAS INTEGRA C 111, TINA-QUANT ALPHA-1 ANTITRYPSIN and CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS.