Apotex Scientific, Inc.
Country not established
- Devices
- 1
What Apotex Scientific, Inc. makes
Apotex Scientific, Inc. manufactures the ANA PROFILE I, a diagnostic device used for detecting antinuclear antibodies (ANA) in serum samples, which aids in the identification of autoimmune diseases.
The ANA PROFILE I 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
Ana Profile I Ref K932424
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Apotex Scientific, Inc. have in the registry?
The registry currently lists 1 device for Apotex Scientific, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apotex Scientific, Inc.'s devices?
Among its 1 most recently registered device, Apotex Scientific, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Apotex Scientific, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Apotex Scientific, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Apotex Scientific, Inc. in the registry?
The most recently registered devices listed for Apotex Scientific, Inc. include ANA PROFILE I.