The Genetics Institute
Country not established
- Devices
- 1
What The Genetics Institute makes
The Genetics Institute manufactures the REFACTO Laboratory Standard, a reagent or diagnostic reagent designed for use in laboratory testing, specifically related to coagulation assays.
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
Refacto Laboratory Standard Ref K002350
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does The Genetics Institute have in the registry?
The registry currently lists 1 device for The Genetics Institute. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Genetics Institute's devices?
Among its 1 most recently registered device, The Genetics Institute has devices listed in FDA 510(k) (1 device).
What risk classes do The Genetics Institute's devices fall under?
Among its 1 most recently registered device, the classes recorded for The Genetics Institute's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from The Genetics Institute in the registry?
The most recently registered devices listed for The Genetics Institute include REFACTO LABORATORY STANDARD.