Specific Diagnostics
United Statesfrom the FDA registration address FDA FEI 3023036790
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3023036790
- Address
- 130 Baytech Dr, San Jose, CA, 95134
- Website
- www.specificdx.com
- linkedin.com/company/biomerieux
From the company website
Since 1963, bioMérieux has been paving the way in the field of in vitro diagnostics and has contributed making the world a healthier place.
Frequently asked questions
How many devices does Specific Diagnostics have in the registry?
The registry currently lists 1 device for Specific Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Specific Diagnostics's devices?
Among its 1 most recently registered device, Specific Diagnostics has devices listed in FDA 510(k) (1 device).
What risk classes do Specific Diagnostics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Specific Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Specific Diagnostics in the registry?
The most recently registered devices listed for Specific Diagnostics include VITEK REVEAL GN AST Assay and VITEK REVEAL AST System.