Janssen Pharmaceutica NV
Country not established
- Devices
- 2
What Janssen Pharmaceutica NV makes
Janssen Pharmaceutica NV manufactures the ODAC-ON Demand Aralgesia by Computer-Infusion Pump, a device designed for controlled delivery of analgesia, and the Idylla Respiratory (IFV-RSV) Panel, a molecular diagnostic test for detecting respiratory pathogens like influenza A/B and respiratory syncytial virus (RSV).
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Idylla Respiratory (IFV-RSV) Panel Ref K163628
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Janssen Pharmaceutica NV have in the registry?
The registry currently lists 2 devices for Janssen Pharmaceutica NV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Janssen Pharmaceutica NV's devices?
Among its 2 most recently registered devices, Janssen Pharmaceutica NV has devices listed in FDA 510(k) (2 devices).
What risk classes do Janssen Pharmaceutica NV's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Janssen Pharmaceutica NV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Janssen Pharmaceutica NV in the registry?
The most recently registered devices listed for Janssen Pharmaceutica NV include ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP and Idylla Respiratory (IFV-RSV) Panel.