Boehringer Mannheim Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 343
What Boehringer Mannheim Corp. makes
The company manufactures diagnostic reagents, control materials, and assay systems for clinical laboratories, including liquid bilirubin reagents, cholesterol controls, and glycero-based calibration standards. It also produces point-of-care testing devices such as lancets for blood glucose monitoring and coagulation analyzers, alongside immunoassay kits for drug and protein detection (e.g., phenytoin, troponin T). Centrifuges for sample processing and blood urea nitrogen (BUN) test strips are also part of its portfolio.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, with many products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the company operates from the United States.
Catalogue
Search and filter all 343 devicesShowing 1-50 of 343
Frequently asked questions
How many devices does Boehringer Mannheim Corp. have in the registry?
The registry currently lists 343 devices for Boehringer Mannheim Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boehringer Mannheim Corp.'s devices?
Among its 50 most recently registered devices, Boehringer Mannheim Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Boehringer Mannheim Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Boehringer Mannheim Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Boehringer Mannheim Corp. in the registry?
The most recently registered devices listed for Boehringer Mannheim Corp. include UNIMETER 330K, PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF, PRECIMAT GLYCEROL and ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844.