Vela Diagnostics USA, Inc.
United Statesfrom the FDA registration address FDA FEI 3009694456
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Vela Diagnostics USA, Inc. makes
Vela Diagnostics USA, Inc. manufactures the Sentosa SA201, a qualitative PCR test for detecting herpes simplex virus types 1 and 2 (HSV-1/2). This device is designed for in vitro diagnostic use to identify viral DNA in clinical samples.
The Sentosa SA201 is classified as a Class II medical device in the U.S. and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Sentosa SA201 HSV 1/2 Qualitative PCR Test Ref K172509
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009694456
- Address
- 353C Route 46W, Fairfield, NJ, 07004
Frequently asked questions
How many devices does Vela Diagnostics USA, Inc. have in the registry?
The registry currently lists 1 device for Vela Diagnostics USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vela Diagnostics USA, Inc.'s devices?
Among its 1 most recently registered device, Vela Diagnostics USA, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Vela Diagnostics USA, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Vela Diagnostics USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vela Diagnostics USA, Inc. in the registry?
The most recently registered devices listed for Vela Diagnostics USA, Inc. include Sentosa SA201 HSV 1/2 Qualitative PCR Test.