Akonni Biosystems, Inc.
Country not established
- Devices
- 1
What Akonni Biosystems, Inc. makes
Akonni Biosystems, Inc. manufactures the TruDiagnosis System, a diagnostic device designed for molecular analysis and pathogen detection, supporting rapid identification of infectious agents in clinical samples.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The system is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
TruDiagnosis System Ref K183530
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Akonni Biosystems, Inc. have in the registry?
The registry currently lists 1 device for Akonni Biosystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Akonni Biosystems, Inc.'s devices?
Among its 1 most recently registered device, Akonni Biosystems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Akonni Biosystems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Akonni Biosystems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Akonni Biosystems, Inc. in the registry?
The most recently registered devices listed for Akonni Biosystems, Inc. include TruDiagnosis System.