Gentris Corporation
Country not established
- Devices
- 1
What Gentris Corporation makes
Gentris Corporation manufactures the Gentrisure Human Genomic DNA Reference Control, a standardized reference material used for validating and calibrating genomic DNA testing procedures in clinical and research settings.
This product 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
Gentrisure Human Genomic Dna Reference Control Ref K063224
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gentris Corporation have in the registry?
The registry currently lists 1 device for Gentris Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gentris Corporation's devices?
Among its 1 most recently registered device, Gentris Corporation has devices listed in FDA 510(k) (1 device).
What risk classes do Gentris Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Gentris Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gentris Corporation in the registry?
The most recently registered devices listed for Gentris Corporation include GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL.