Invivoscribe Technologies, Inc.
Country not established
- Devices
- 1
What Invivoscribe Technologies, Inc. makes
Invivoscribe Technologies, Inc. develops the LeukoStrat CDx FLT3 Mutation Assay, a diagnostic test designed to detect mutations in the FLT3 gene for use in acute myeloid leukemia (AML) patient stratification.
This product is classified as a Class III medical device under FDA regulations and is listed under a Premarket Approval Application (PMA). The company is based in the United States.
Catalogue
LeukoStrat CDx FLT3 Mutation Assay Ref P160040
Regimes: CE IVDR PMA Registry: PMA
Frequently asked questions
How many devices does Invivoscribe Technologies, Inc. have in the registry?
The registry currently lists 1 device for Invivoscribe Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Invivoscribe Technologies, Inc.'s devices?
Among its 1 most recently registered device, Invivoscribe Technologies, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Invivoscribe Technologies, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Invivoscribe Technologies, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Invivoscribe Technologies, Inc. in the registry?
The most recently registered devices listed for Invivoscribe Technologies, Inc. include LeukoStrat CDx FLT3 Mutation Assay.