Roche Analytical Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 11
What Roche Analytical Instruments, Inc. makes
The company produces diagnostic reagents for use in automated clinical chemistry analyzers, including COBAS-branded reagents for measuring liver function markers (such as ALT, AST, bilirubin, and alkaline phosphatase), kidney function (BUN), cardiac markers (CK-NAC), lipid profiles (cholesterol, triglycerides), glucose levels, and uric acid. These reagents are designed for in vitro testing to support clinical decision-making in laboratory settings.
The portfolio includes Class I and Class II devices, with regulatory submissions filed under the FDA’s 510(k) pathway. These reagents are intended for use in the United States, where they are listed with the FDA. The company is based in the US.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Roche Analytical Instruments, Inc. have in the registry?
The registry currently lists 11 devices for Roche Analytical Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roche Analytical Instruments, Inc.'s devices?
Among its 11 most recently registered devices, Roche Analytical Instruments, Inc. has devices listed in FDA 510(k) (11 devices).
What risk classes do Roche Analytical Instruments, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Roche Analytical Instruments, 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 Analytical Instruments, Inc. in the registry?
The most recently registered devices listed for Roche Analytical Instruments, Inc. include COBAS REAGENT FOR A-AMYLASE, COBAS REAGENT FOR AST (SGOT), COBAS TOTAL BILIRUBIN REAGENT & DILUENT and COBAS REAGENTS FOR URIC ACID.