Kenota, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Kenota, Inc. makes
Kenota, Inc. manufactures the Kenota 1 Total IgE test system, a diagnostic device used to measure total immunoglobulin E (IgE) levels in patient samples, along with the Kenota 1 instrument for processing these tests.
The company’s portfolio is regulated under FDA’s Class II device classification and requires 510(k) clearance. The devices are listed in the FDA’s 510(k) database. Kenota, Inc. is based in the United States.
Catalogue
Kenota 1 Total IgE; Kenota 1 (instrument) Ref K231151
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kenota, Inc. have in the registry?
The registry currently lists 1 device for Kenota, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kenota, Inc.'s devices?
Among its 1 most recently registered device, Kenota, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Kenota, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Kenota, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kenota, Inc. in the registry?
The most recently registered devices listed for Kenota, Inc. include Kenota 1 Total IgE; Kenota 1 (instrument).