Theranos, Inc.
Country not established
- Devices
- 1
What Theranos, Inc. makes
Theranos, Inc. develops in vitro diagnostic tests, including the Herpes Simplex Virus-1 IgG Assay, which detects immunoglobulin G antibodies to HSV-1 for diagnostic purposes.
The company’s diagnostic tests fall under FDA Class II devices and are authorised via the 510(k) pathway. The portfolio is regulated under US FDA standards, and the company is based in the United States.
Catalogue
Theranos Herpes Simplex Virus-1 IgG Assay Ref K143236
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Theranos, Inc. have in the registry?
The registry currently lists 1 device for Theranos, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Theranos, Inc.'s devices?
Among its 1 most recently registered device, Theranos, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Theranos, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Theranos, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Theranos, Inc. in the registry?
The most recently registered devices listed for Theranos, Inc. include Theranos Herpes Simplex Virus-1 IgG Assay.