GenDx LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000052622
- Devices
- 1
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
ImmunoFLOW Mycoplasma IgM Control Ref 3925
Regimes: CE IVDD Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000052622
- EUDAMED status
- Active
- EUDAMED registered name
- GenDx LLC
- EUDAMED abbreviated name
- GenBio
- Registered address
- 15222, Avenue of Science, 92128, San Diego, United States
- Website
- www.genbio.com/
- [email protected]
- Phone
- +1 (858)592-9300
- PRRC contact
- Elisa Romeo
From the company website
Find out how GenDx LLC dba GenBio is revolutionizing diagnostics with their cutting-edge biotechnology products.
Frequently asked questions
How many devices does GenDx LLC have in the registry?
The registry currently lists 1 device for GenDx LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list GenDx LLC's devices?
Among its 1 most recently registered device, GenDx LLC has devices listed in EUDAMED (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GenDx LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for GenDx LLC's devices are IVD general. Each device page shows its own class and authorisation.
What are the newest devices from GenDx LLC in the registry?
The most recently registered devices listed for GenDx LLC include ImmunoFLOW Mycoplasma IgM Control.