Paragondx, LLC
Country not established
- Devices
- 1
What Paragondx, LLC makes
Paragondx, LLC manufactures the RAPID GENOTYPING ASSAY for CYP2C9 and VKORC1 genes, a molecular diagnostic test used to identify genetic variations associated with drug metabolism and vitamin K antagonist sensitivity.
This assay 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
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Paragondx, LLC have in the registry?
The registry currently lists 1 device for Paragondx, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Paragondx, LLC's devices?
Among its 1 most recently registered device, Paragondx, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Paragondx, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Paragondx, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Paragondx, LLC in the registry?
The most recently registered devices listed for Paragondx, LLC include RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA.