Autoimmunity Diagnostics Corp.
Country not established
- Devices
- 1
What Autoimmunity Diagnostics Corp. makes
Autoimmunity Diagnostics Corp. manufactures the ANA-5 Autoantibody Profile Kit, a diagnostic test designed to detect specific autoantibodies associated with autoimmune diseases.
The company’s portfolio is regulated under FDA Class II devices and is listed via the 510(k) clearance pathway. The products are based in the United States.
Catalogue
Ana-5 Autoantibody Profile Kit Ref K885224
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Autoimmunity Diagnostics Corp. have in the registry?
The registry currently lists 1 device for Autoimmunity Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Autoimmunity Diagnostics Corp.'s devices?
Among its 1 most recently registered device, Autoimmunity Diagnostics Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Autoimmunity Diagnostics Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Autoimmunity Diagnostics Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Autoimmunity Diagnostics Corp. in the registry?
The most recently registered devices listed for Autoimmunity Diagnostics Corp. include ANA-5 AUTOANTIBODY PROFILE KIT.