Sangstat Medical Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Sangstat Medical Corp. makes
Sangstat Medical Corp. produces the CELSIOR system, a cold storage and transport solution designed for preserving hearts during transport, as well as the THYMOSTAT ELISA test for detecting human IgG, IgM, and IgA antibodies against rabbit IgG. The company also manufactures the CYCLOTECH dispenser, which administers cyclosporine oral solutions in controlled doses.
The company’s devices are classified under FDA’s Class I and Class II categories and are subject to 510(k) clearance requirements. These products are listed in the FDA’s regulatory database, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Cyclotech Cyclosporine Oral Solutions Dispenser Ref K980109
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sangstat Medical Corp. have in the registry?
The registry currently lists 3 devices for Sangstat Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sangstat Medical Corp.'s devices?
Among its 3 most recently registered devices, Sangstat Medical Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sangstat Medical Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sangstat Medical Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sangstat Medical Corp. in the registry?
The most recently registered devices listed for Sangstat Medical Corp. include CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS, THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG, M AND A ANTI-RABBIT IGG ANTIBODIES and CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER.