Truvian Health
Country not established
- Devices
- 4
What Truvian Health makes
Truvian Health manufactures point-of-care diagnostic test panels and analyzers, including the Tru Kidney Health Test Panel and Tru Liver Health Test Panel, as well as lipid and core metabolic testing solutions. These products are designed for rapid, on-site analysis of patient health markers, such as kidney and liver function indicators, without requiring centralized lab facilities.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions supported through the 510(k) pathway. Products are listed with the FDA and are intended for use in the United States.
Catalogue
Lipids Ref K251091
510(k) 510(k)Tru Kidney Health Test Panel; Tru Analyzer Ref K251058
510(k) 510(k)Core Metabolic Ref K251157
510(k) 510(k)Tru Liver Health Test Panel Ref K251074
510(k) 510(k)
Frequently asked questions
How many devices does Truvian Health have in the registry?
The registry currently lists 4 devices for Truvian Health. Devices recorded under merged duplicate company entries are counted once.
Which registries list Truvian Health's devices?
Among its 4 most recently registered devices, Truvian Health has devices listed in FDA 510(k) (4 devices).
What risk classes do Truvian Health's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Truvian Health's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Truvian Health in the registry?
The most recently registered devices listed for Truvian Health include Lipids, Tru Kidney Health Test Panel; Tru Analyzer, Core Metabolic and Tru Liver Health Test Panel.