Roche Diagnostic Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 296
What Roche Diagnostic Systems, Inc. makes
Roche Diagnostic Systems, Inc. manufactures diagnostic reagents and systems for laboratory testing, including immunoassay systems like the COBAS Core Immunochemistry System, as well as specific reagents for measuring substances such as cocaine metabolites, apolipoprotein B, bilirubin, and hemoglobin A1c. The company also produces drug testing kits for substances like amphetamines, methadone, and morphine, alongside calibrators and controls for these assays.
These devices are classified under FDA categories Class I, Class II, and Unclassified (U), with regulatory submissions recorded in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Search and filter all 296 devicesShowing 1-50 of 296
Frequently asked questions
How many devices does Roche Diagnostic Systems, Inc. have in the registry?
The registry currently lists 296 devices for Roche Diagnostic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roche Diagnostic Systems, Inc.'s devices?
Among its 50 most recently registered devices, Roche Diagnostic Systems, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Roche Diagnostic Systems, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Roche Diagnostic Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Roche Diagnostic Systems, Inc. in the registry?
The most recently registered devices listed for Roche Diagnostic Systems, Inc. include ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE, COBAS CORE IMMUNOCHEMISTRY SYSTEM, ROCHE REAGENT FOR APOLIPOPROTEIN B and ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P.