Nyu Langone Medical Center
Country not established
- Devices
- 1
What Nyu Langone Medical Center makes
The NYU Langone Genome PACT is a laboratory-developed test used for genome profiling of actionable cancer targets, identifying genetic mutations in tumor samples to guide precision oncology treatments.
This device is classified as Class II under FDA regulations and is listed via the 510(k) pathway. The product is developed and supported by NYU Langone Medical Center in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nyu Langone Medical Center have in the registry?
The registry currently lists 1 device for Nyu Langone Medical Center. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nyu Langone Medical Center's devices?
Among its 1 most recently registered device, Nyu Langone Medical Center has devices listed in FDA 510(k) (1 device).
What risk classes do Nyu Langone Medical Center's devices fall under?
Among its 1 most recently registered device, the classes recorded for Nyu Langone Medical Center's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nyu Langone Medical Center in the registry?
The most recently registered devices listed for Nyu Langone Medical Center include NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets).