Healgen
Country not established
- Devices
- 1
What Healgen makes
Healgen produces rapid antigen tests for the detection of COVID-19 and influenza A & B viruses, designed for point-of-care use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Healgen Rapid Check COVID-19/Flu A&B Antigen Test Ref DEN240029
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Healgen have in the registry?
The registry currently lists 1 device for Healgen. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healgen's devices?
Among its 1 most recently registered device, Healgen has devices listed in FDA 510(k) (1 device).
What risk classes do Healgen's devices fall under?
Among its 1 most recently registered device, the classes recorded for Healgen's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healgen in the registry?
The most recently registered devices listed for Healgen include Healgen Rapid Check COVID-19/Flu A&B Antigen Test.