Roche Diagnostics/Boehringer Mannheim GmbH
Country not established
- Devices
- 3
What Roche Diagnostics/Boehringer Mannheim GmbH makes
The company produces in vitro diagnostic reagents and assays for laboratory testing, including folate measurement kits (CEDIA RED BLOOD CELL FOLATE REAGENT PACK, ELECSYS FOLATE ASSAY) and liquid bilirubin reagents (ROCHE DIAGNOSTICS TOTAL BILIRUBIN REAGENT). It also manufactures point-of-care coagulation testing systems (COAGUCHEK PRO SYSTEM) with associated test cartridges and controls (APTT TEST CARTRIDGES, COAGUCHEK P).
These products are classified as Class II medical devices under FDA regulations and are recorded in the 510(k) premarket notification database. The company operates with a US-based presence.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Roche Diagnostics/Boehringer Mannheim GmbH have in the registry?
The registry currently lists 3 devices for Roche Diagnostics/Boehringer Mannheim GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roche Diagnostics/Boehringer Mannheim GmbH's devices?
Among its 3 most recently registered devices, Roche Diagnostics/Boehringer Mannheim GmbH has devices listed in FDA 510(k) (3 devices).
What risk classes do Roche Diagnostics/Boehringer Mannheim GmbH's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Roche Diagnostics/Boehringer Mannheim GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roche Diagnostics/Boehringer Mannheim GmbH in the registry?
The most recently registered devices listed for Roche Diagnostics/Boehringer Mannheim GmbH include CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY, ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT and COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P.