Sienna Biotech, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Sienna Biotech, Inc. makes
Sienna Biotech, Inc. manufactures immunoassay systems and total antibody assays for infectious disease testing, including tests for Toxoplasma gondii, Rubella, and cytomegalovirus (CMV). These products are designed for laboratory use to detect specific antibodies in patient samples, aiding in the diagnosis of infections.
The company’s portfolio is regulated under FDA Class II devices and is listed via the 510(k) clearance pathway. These products are intended for use in the United States, where they are subject to compliance with FDA regulatory requirements.
Catalogue
Copalis Torc Total Antibody Assay Ref K970931
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Copalis Cmv Total Antibody Assay Ref K955799
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sienna Biotech, Inc. have in the registry?
The registry currently lists 3 devices for Sienna Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sienna Biotech, Inc.'s devices?
Among its 3 most recently registered devices, Sienna Biotech, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Sienna Biotech, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sienna Biotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sienna Biotech, Inc. in the registry?
The most recently registered devices listed for Sienna Biotech, Inc. include COPALIS TORC TOTAL ANTIBODY ASSAY, COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS and COPALIS CMV TOTAL ANTIBODY ASSAY.