Boehringer Mannheim Corp.

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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.