Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
Country not established
- Devices
- 1
What Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC makes
Focus Diagnostics, Inc., doing business as Diasorin Molecular, LLC, manufactures in vitro diagnostic test kits for the detection of Clostridioides difficile, including the Simplexa C. difficile Direct assay and its associated positive control pack.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC have in the registry?
The registry currently lists 1 device for Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC's devices?
Among its 1 most recently registered device, Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC in the registry?
The most recently registered devices listed for Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC include Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack.