Rheonix, Inc.
Country not established
- Devices
- 1
What Rheonix, Inc. makes
Rheonix, Inc. manufactures diagnostic instruments and associated software, including the Rheonix EncompassMDx Workstation for automated processing of infectious disease assays. The company also produces the Rheonix STI TriPlex Assay for detecting sexually transmitted infections and urine specimen collection kits for sample preparation.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where Rheonix, Inc. is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rheonix, Inc. have in the registry?
The registry currently lists 1 device for Rheonix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rheonix, Inc.'s devices?
Among its 1 most recently registered device, Rheonix, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Rheonix, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Rheonix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rheonix, Inc. in the registry?
The most recently registered devices listed for Rheonix, Inc. include Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit.