Leica Biosystems
Country not established
- Devices
- 1
What Leica Biosystems makes
Leica Biosystems manufactures the BOND ORACLE HER2 immunohistochemistry (IHC) system, a diagnostic device designed for automated analysis of HER2 protein expression in tissue samples. This system supports pathology workflows by providing precise, standardized results for breast cancer diagnostics, aiding in treatment decision-making.
The BOND ORACLE HER2 IHC system is classified as a Class III medical device under FDA regulations and is listed under a Premarket Approval (PMA) application. The company operates with a US headquarters and adheres to regulatory requirements for high-risk devices in the United States.
Catalogue
Bond Oracle HER2 Ihc System Ref P090015
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Leica Biosystems have in the registry?
The registry currently lists 1 device for Leica Biosystems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Leica Biosystems's devices?
Among its 1 most recently registered device, Leica Biosystems has devices listed in FDA PMA (1 device).
What risk classes do Leica Biosystems's devices fall under?
Among its 1 most recently registered device, the classes recorded for Leica Biosystems's devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Leica Biosystems in the registry?
The most recently registered devices listed for Leica Biosystems include BOND ORACLE HER2 IHC SYSTEM.