Alere San Diego, Incorporated
Country not established
- Devices
- 1
What Alere San Diego, Incorporated makes
Alere San Diego, Incorporated manufactures diagnostic test devices for detecting H. pylori infection, including the Alere Signify H. pylori test and the Alere Clearview H. pylori test, which are designed for use with whole blood, serum, or plasma specimens.
These devices are classified as Class I 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 Alere San Diego, Incorporated have in the registry?
The registry currently lists 1 device for Alere San Diego, Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alere San Diego, Incorporated's devices?
Among its 1 most recently registered device, Alere San Diego, Incorporated has devices listed in FDA 510(k) (1 device).
What risk classes do Alere San Diego, Incorporated's devices fall under?
Among its 1 most recently registered device, the classes recorded for Alere San Diego, Incorporated's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Alere San Diego, Incorporated in the registry?
The most recently registered devices listed for Alere San Diego, Incorporated include Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only.