Scanadu, Inc.
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- Devices
- 1
What Scanadu, Inc. makes
Scanadu, Inc. manufactures the inui In-Home Urine Analysis Test System, a diagnostic device designed for at-home urine testing to detect and monitor conditions such as urinary tract infections, kidney function, and metabolic health. The system provides quantitative analysis of key urine parameters, including pH, specific gravity, protein, glucose, ketones, blood, and nitrites, enabling users to track health trends without clinical lab visits.
The inui In-Home Urine Analysis Test System is classified as a Class II medical device under FDA regulations and requires 510(k) clearance. The device is listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards for in vitro diagnostic devices. The company is based in the United States.
Catalogue
inui In-Home Urine Analysis Test System Ref K180356
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scanadu, Inc. have in the registry?
The registry currently lists 1 device for Scanadu, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scanadu, Inc.'s devices?
Among its 1 most recently registered device, Scanadu, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Scanadu, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Scanadu, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scanadu, Inc. in the registry?
The most recently registered devices listed for Scanadu, Inc. include inui In-Home Urine Analysis Test System.