Bartels Prognostics, Inc.
Country not established
- Devices
- 1
What Bartels Prognostics, Inc. makes
Bartels Prognostics, Inc. develops the Bartels Chemoresponse Assay, a diagnostic test used to evaluate a patient’s likelihood of responding to specific chemotherapy treatments for cancer. The assay helps guide personalized treatment decisions by assessing cellular responses to multiple chemotherapy drugs in vitro.
The Chemoresponse Assay is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA) application for authorization. The company is based in the United States, where its device is listed with the FDA.
Catalogue
Bartels Chemoresponse Assay Ref P940036
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Bartels Prognostics, Inc. have in the registry?
The registry currently lists 1 device for Bartels Prognostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bartels Prognostics, Inc.'s devices?
Among its 1 most recently registered device, Bartels Prognostics, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Bartels Prognostics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bartels Prognostics, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Bartels Prognostics, Inc. in the registry?
The most recently registered devices listed for Bartels Prognostics, Inc. include BARTELS CHEMORESPONSE ASSAY.