Immunogenetics
Country not established
- Devices
- 1
What Immunogenetics makes
Immunogenetics manufactures platelet control reagents used in laboratory diagnostics to ensure the accuracy of platelet function assays and coagulation testing.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. The company operates from the United States.
Catalogue
Control Diagnostics Platelet Control Ref K821851
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Immunogenetics have in the registry?
The registry currently lists 1 device for Immunogenetics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Immunogenetics's devices?
Among its 1 most recently registered device, Immunogenetics has devices listed in FDA 510(k) (1 device).
What risk classes do Immunogenetics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Immunogenetics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Immunogenetics in the registry?
The most recently registered devices listed for Immunogenetics include CONTROL DIAGNOSTICS PLATELET CONTROL.