American Dade
Country not established
- Devices
- 149
What American Dade makes
American Dade manufactures diagnostic reagents for clinical chemistry and immunoassay testing, including creatine kinase MB, lactate, uric acid, cortisol, and thyroid uptake assays. Their portfolio also covers enzyme-based assays like phenytoin and N-acetyl-β-glucosaminidase (NAPA), as well as reagents for measuring carbon dioxide and iron levels. Bovine chemistry controls are provided for quality assurance in laboratory settings.
The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) device categories, with many authorised via the 510(k) pathway. These reagents are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 149 devicesShowing 1-50 of 149
Frequently asked questions
How many devices does American Dade have in the registry?
The registry currently lists 149 devices for American Dade. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Dade's devices?
Among its 50 most recently registered devices, American Dade has devices listed in FDA 510(k) (50 devices).
What risk classes do American Dade's devices fall under?
Among its 50 most recently registered devices, the classes recorded for American Dade's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Dade in the registry?
The most recently registered devices listed for American Dade include CREATINE KINASE MB REAGENT, STRATUS PHENYTOIN FLUOROMETRIC ENZYME, LACTATE REAGENT and PARAMAX IRON BLANK REAGENT.