Diagnostics Direct, LLC
Country not established
- Devices
- 1
What Diagnostics Direct, LLC makes
Diagnostics Direct, LLC manufactures the Syphilis Health Check, a diagnostic test designed to detect syphilis infection through laboratory analysis.
The Syphilis Health Check is classified as a Class II medical device in the US and is authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Syphilis Health Check Ref K102400
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diagnostics Direct, LLC have in the registry?
The registry currently lists 1 device for Diagnostics Direct, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnostics Direct, LLC's devices?
Among its 1 most recently registered device, Diagnostics Direct, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Diagnostics Direct, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Diagnostics Direct, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnostics Direct, LLC in the registry?
The most recently registered devices listed for Diagnostics Direct, LLC include SYPHILIS HEALTH CHECK.