Vermillion, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Vermillion, Inc. makes
Vermillion, Inc. develops the OVA1 Next Generation, a blood-based diagnostic test designed to assess the risk of ovarian cancer in women with pelvic masses.
The company’s portfolio is regulated under FDA’s Class II device classification, with the OVA1 Next Generation authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
OVA1 Test Ref DEN090004
Regimes: De Novo Registry: De NovoOVA1 Next Generation Ref K150588
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Vermillion, Inc. have in the registry?
The registry currently lists 2 devices for Vermillion, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vermillion, Inc.'s devices?
Among its 2 most recently registered devices, Vermillion, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Vermillion, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Vermillion, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vermillion, Inc. in the registry?
The most recently registered devices listed for Vermillion, Inc. include OVA1 TEST and OVA1 Next Generation.