Abbott Diagnostics
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- Devices
- 29
What Abbott Diagnostics makes
The company manufactures hematology analyzers, including automated multi-parameter systems like the CELL-DYN 3000, CELL-DYN 4000, and CELL-DYN 800, designed for whole blood analysis. It also produces specialized reagents, such as the CELL-DYN Rapid-Lyse and hemoglobin testing kits, isotonic diluents, and platelet-specific analyzers like the CELL-DYN 100. Spectrophotometers, including the Model 340 and Model 690, are part of the portfolio, alongside controls like the ABBOTT Strep A Controls for diagnostic testing.
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The portfolio is listed in the FDA’s 510(k) registry, and the company is based in the United States.
Catalogue
Search and filter all 29 devicesFrequently asked questions
How many devices does Abbott Diagnostics have in the registry?
The registry currently lists 29 devices for Abbott Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Diagnostics's devices?
Among its 29 most recently registered devices, Abbott Diagnostics has devices listed in FDA 510(k) (29 devices).
What risk classes do Abbott Diagnostics's devices fall under?
Among its 29 most recently registered devices, the classes recorded for Abbott Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Abbott Diagnostics in the registry?
The most recently registered devices listed for Abbott Diagnostics include CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER, MODEL 340 SPECTROPHOTOMETER, CELL DYN 800 HEMATOLOGY ANALYZER and CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY.