Aktis Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Aktis Corp. makes
Aktis Corp. manufactures IMMPULSE Cortisol Assay Reagents and IMMPULSE Digoxin Assay Reagents, which are in vitro diagnostic reagents designed for measuring cortisol and digoxin levels in patient samples.
These products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Immpulse Cortisol Assay Reagents Ref K842554
Regimes: 510(k) Registry: 510(k)Immpulse Digoxin Assay Reagents Ref K842571
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Aktis Corp. have in the registry?
The registry currently lists 2 devices for Aktis Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aktis Corp.'s devices?
Among its 2 most recently registered devices, Aktis Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Aktis Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Aktis Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aktis Corp. in the registry?
The most recently registered devices listed for Aktis Corp. include IMMPULSE CORTISOL ASSAY REAGENTS and IMMPULSE DIGOXIN ASSAY REAGENTS.