Alpha Antigens, Inc.
Country not established
- Devices
- 1
What Alpha Antigens, Inc. makes
Alpha Antigens, Inc. manufactures diagnostic reagents designed to detect nuclear antigens, used primarily in serological testing for autoimmune diseases and infectious disease diagnostics.
These products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Nuclear Antigens Ref K810592
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alpha Antigens, Inc. have in the registry?
The registry currently lists 1 device for Alpha Antigens, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alpha Antigens, Inc.'s devices?
Among its 1 most recently registered device, Alpha Antigens, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Alpha Antigens, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Alpha Antigens, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alpha Antigens, Inc. in the registry?
The most recently registered devices listed for Alpha Antigens, Inc. include NUCLEAR ANTIGENS.