Biocartis US, Inc.
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- Devices
- 1
What Biocartis US, Inc. makes
Biocartis US, Inc. manufactures the Idylla CDx MSI Test, a molecular diagnostic device designed for detecting microsatellite instability (MSI) in formalin-fixed, paraffin-embedded (FFPE) tissue samples. This test is intended for use in identifying patients with specific tumor types who may benefit from immunotherapy.
The Idylla CDx MSI Test is classified as a Class III medical device under FDA regulations and is authorised via a Premarket Approval (PMA) application. The company is based in the United States.
Catalogue
Idylla CDx MSI Test Ref P250005
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Biocartis Us, Inc. have in the registry?
The registry currently lists 1 device for Biocartis Us, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocartis Us, Inc.'s devices?
Among its 1 most recently registered device, Biocartis Us, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Biocartis Us, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biocartis Us, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Biocartis Us, Inc. in the registry?
The most recently registered devices listed for Biocartis Us, Inc. include Idylla CDx MSI Test.