Reprobitech Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Reprobitech Corp. makes
Reprobitech Corp. manufactures single-use devices for blood collection and processing, including the iVitri EZ—a closed-system blood collection set—and the iVitri Straw—a sterile transfer straw for laboratory use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
iVitri EZ Ref K162640
Regimes: 510(k) Registry: 510(k)iVitri Straw Ref K172751
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Reprobitech Corp. have in the registry?
The registry currently lists 2 devices for Reprobitech Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Reprobitech Corp.'s devices?
Among its 2 most recently registered devices, Reprobitech Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Reprobitech Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Reprobitech Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Reprobitech Corp. in the registry?
The most recently registered devices listed for Reprobitech Corp. include iVitri EZ and iVitri Straw.