Epitope, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Epitope, Inc. makes
Epitope, Inc. manufactures the EPISCREEN Oral Specimen Collection Device, designed for collecting oral fluid samples, and the EPISCREEN system, which processes and analyzes those samples for diagnostic purposes.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States, where Epitope, Inc. is based.
Catalogue
Episcreen Oral Specimen Collection Device Ref K973395
Regimes: 510(k) Registry: 510(k)Episcreen Ref K970357
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Epitope, Inc. have in the registry?
The registry currently lists 2 devices for Epitope, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epitope, Inc.'s devices?
Among its 2 most recently registered devices, Epitope, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Epitope, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Epitope, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Epitope, Inc. in the registry?
The most recently registered devices listed for Epitope, Inc. include EPISCREEN ORAL SPECIMEN COLLECTION DEVICE and EPISCREEN.