Virotech Diagnostika
Country not established
- Devices
- 1
What Virotech Diagnostika makes
Virotech Diagnostika manufactures the IGG Subclass Enzyme Immunoassay (EIA) test, a diagnostic device used to measure specific immunoglobulin G subclasses in serum or plasma samples. This assay aids in the evaluation of immune responses and potential deficiencies in IgG subclasses.
The IGG Subclass EIA is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Igg Suclass Eia Ref K921575
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Virotech Diagnostika have in the registry?
The registry currently lists 1 device for Virotech Diagnostika. Devices recorded under merged duplicate company entries are counted once.
Which registries list Virotech Diagnostika's devices?
Among its 1 most recently registered device, Virotech Diagnostika has devices listed in FDA 510(k) (1 device).
What risk classes do Virotech Diagnostika's devices fall under?
Among its 1 most recently registered device, the classes recorded for Virotech Diagnostika's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Virotech Diagnostika in the registry?
The most recently registered devices listed for Virotech Diagnostika include IGG SUCLASS EIA.