Kabivitrum, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Kabivitrum, Inc. makes
Kabivitrum, Inc. manufactures coated diagnostic reagents for coagulation testing, including Coatest Plasmogen, Coatest Heparin, Coatest Factor VIII, Coatest Antithrombin, Coatest Antipiasmin, Coatest Factor X, and Coatest Protein C. The company also produces intravenous (I.V.) bags designed for medical administration.
These products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company is based in the United States.
Catalogue
Coatest Plasminogen Ref K854572
Regimes: 510(k) Registry: 510(k)Coatest Heparin Ref K833891
Regimes: 510(k) Registry: 510(k)The I.V. Bag Ref K844664
Regimes: 510(k) Registry: 510(k)Coatest Factor Viii Ref K833892
Regimes: 510(k) Registry: 510(k)Coatest Antithrombin Ref K812829
Regimes: 510(k) Registry: 510(k)Coatest Antiplasmin Ref K833890
Regimes: 510(k) Registry: 510(k)Coatest Factor X Ref K832114
Regimes: 510(k) Registry: 510(k)Coatest Protein C Ref K884058
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kabivitrum, Inc. have in the registry?
The registry currently lists 8 devices for Kabivitrum, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kabivitrum, Inc.'s devices?
Among its 8 most recently registered devices, Kabivitrum, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Kabivitrum, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Kabivitrum, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kabivitrum, Inc. in the registry?
The most recently registered devices listed for Kabivitrum, Inc. include COATEST PLASMINOGEN, COATEST HEPARIN, THE I.V. BAG and COATEST FACTOR VIII.