Myriad Genetic Laboratories, Inc.
Country not established
- Devices
- 1
What Myriad Genetic Laboratories, Inc. makes
Myriad Genetic Laboratories, Inc. develops and provides the myChoice CDx genetic test, a diagnostic tool used for hereditary cancer risk assessment and genetic counseling. This test analyzes specific gene mutations associated with an increased risk of certain cancers, aiding in personalized screening and management strategies for patients.
The myChoice CDx is classified as a Class III medical device under FDA regulations and requires Premarket Approval (PMA) authorization. The company is headquartered in the United States, where its product is listed for regulatory compliance.
Catalogue
myChoice CDx Ref P190014
Regimes: PMA Registry: PMA
Company details
- Website
- www.myriad.com
- facebook.com/MyriadGenetics
From the company website
Myriad Genetics hereditary cancer, prenatal, oncology and mental health genetic testing insights can help detect, treat and prevent disease. Get started today.
Frequently asked questions
How many devices does Myriad Genetic Laboratories, Inc. have in the registry?
The registry currently lists 1 device for Myriad Genetic Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Myriad Genetic Laboratories, Inc.'s devices?
Among its 1 most recently registered device, Myriad Genetic Laboratories, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Myriad Genetic Laboratories, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Myriad Genetic Laboratories, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Myriad Genetic Laboratories, Inc. in the registry?
The most recently registered devices listed for Myriad Genetic Laboratories, Inc. include myChoice CDx.