Janssen Diagnostics
Country not established
- Devices
- 1
What Janssen Diagnostics makes
Janssen Diagnostics manufactures the GeneSearch Breast Lymph Node (BLN) Assay, a molecular diagnostic test designed to detect breast cancer cells in sentinel lymph nodes during surgery. This in vitro diagnostic device aids in determining whether additional lymph node removal is necessary based on genetic analysis of tissue samples.
The GeneSearch BLN Assay is classified as a Class III medical device in the US and is listed under the FDA’s Premarket Approval (PMA) pathway. The company is based in the United States.
Catalogue
Genesearch Breast Lymph Node (Bln) Assay Ref P060017
Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Janssen Diagnostics have in the registry?
The registry currently lists 1 device for Janssen Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Janssen Diagnostics's devices?
Among its 1 most recently registered device, Janssen Diagnostics has devices listed in FDA PMA (1 device).
What risk classes do Janssen Diagnostics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Janssen Diagnostics's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Janssen Diagnostics in the registry?
The most recently registered devices listed for Janssen Diagnostics include GENESEARCH BREAST LYMPH NODE (BLN) ASSAY.