Virotech, Inc.
Country not established
- Devices
- 1
What Virotech, Inc. makes
Virotech, Inc. manufactures the Cytomegalovirus (CMV) ELISA, an in vitro diagnostic test designed to detect antibodies against CMV in human serum or plasma. This assay supports serological testing for CMV infection, aiding in the assessment of immune status and infection risk.
The CMV ELISA 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
Cytomegalovirus (Cmv) Elisa Ref K904456
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Virotech, Inc. have in the registry?
The registry currently lists 1 device for Virotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Virotech, Inc.'s devices?
Among its 1 most recently registered device, Virotech, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Virotech, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Virotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Virotech, Inc. in the registry?
The most recently registered devices listed for Virotech, Inc. include CYTOMEGALOVIRUS (CMV) ELISA.