Compass Bioscience
Country not established
- Devices
- 2
What Compass Bioscience makes
Compass Bioscience manufactures control and verification sets for cardiac markers, including validation tools for laboratory testing. The company also produces hemoglobin A1c (HbA1c) controls, which are used to monitor and ensure the accuracy of diabetes management assays in clinical settings.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- 510(k) 510(k)
Hemoglobin Alc Control Ref K060570
510(k) 510(k)
Frequently asked questions
How many devices does Compass Bioscience have in the registry?
The registry currently lists 2 devices for Compass Bioscience. Devices recorded under merged duplicate company entries are counted once.
Which registries list Compass Bioscience's devices?
Among its 2 most recently registered devices, Compass Bioscience has devices listed in FDA 510(k) (2 devices).
What risk classes do Compass Bioscience's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Compass Bioscience's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Compass Bioscience in the registry?
The most recently registered devices listed for Compass Bioscience include CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET and HEMOGLOBIN ALC CONTROL.