Prognostix, Inc.
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- Devices
- 1
What Prognostix, Inc. makes
Prognostix, Inc. manufactures the CardioMpo Test, a diagnostic device used for assessing cardiac biomarkers to support clinical decision-making.
The company’s portfolio is regulated under FDA’s Class II device classification, with the CardioMpo Test authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Cardiompo Test Ref K050029
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prognostix, Inc. have in the registry?
The registry currently lists 1 device for Prognostix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prognostix, Inc.'s devices?
Among its 1 most recently registered device, Prognostix, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Prognostix, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Prognostix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prognostix, Inc. in the registry?
The most recently registered devices listed for Prognostix, Inc. include CARDIOMPO TEST.