Janssen Research Foundation
Country not established
- Devices
- 1
What Janssen Research Foundation makes
The company produces diagnostic test kits, including ELISA (enzyme-linked immunosorbent assay) systems for detecting human IgG subclasses. These kits are designed for laboratory use to quantify specific antibody levels in serum or plasma samples.
The portfolio is regulated under FDA’s Class II device classification and includes products authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Elisa Combi-Kit Human Igg Subclasses Ref K911610
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Janssen Research Foundation have in the registry?
The registry currently lists 1 device for Janssen Research Foundation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Janssen Research Foundation's devices?
Among its 1 most recently registered device, Janssen Research Foundation has devices listed in FDA 510(k) (1 device).
What risk classes do Janssen Research Foundation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Janssen Research Foundation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Janssen Research Foundation in the registry?
The most recently registered devices listed for Janssen Research Foundation include ELISA COMBI-KIT HUMAN IGG SUBCLASSES.