Karolinska Institutet
Country not established
- Devices
- 1
What Karolinska Institutet makes
Karolinska Institutet manufactures EDTA gel tubes, a type of blood collection tube used for anticoagulation and serum separation in laboratory diagnostics.
The EDTA gel tube is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Edta Gel (Tm) Ref K940737
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Karolinska Institutet have in the registry?
The registry currently lists 1 device for Karolinska Institutet. Devices recorded under merged duplicate company entries are counted once.
Which registries list Karolinska Institutet's devices?
Among its 1 most recently registered device, Karolinska Institutet has devices listed in FDA 510(k) (1 device).
What risk classes do Karolinska Institutet's devices fall under?
Among its 1 most recently registered device, the classes recorded for Karolinska Institutet's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Karolinska Institutet in the registry?
The most recently registered devices listed for Karolinska Institutet include EDTA GEL (TM).