Scimedx Tekfile Services
Country not established
- Devices
- 1
What Scimedx Tekfile Services makes
Scimedx Tekfile Services manufactures the SERODIA TP-PA, a diagnostic test used for detecting antibodies to Treponema pallidum, the bacterium responsible for syphilis. This device aids in serological testing to confirm syphilis infection.
The SERODIA TP-PA is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Serodia Tp-Pa Ref K971502
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scimedx Tekfile Services have in the registry?
The registry currently lists 1 device for Scimedx Tekfile Services. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scimedx Tekfile Services's devices?
Among its 1 most recently registered device, Scimedx Tekfile Services has devices listed in FDA 510(k) (1 device).
What risk classes do Scimedx Tekfile Services's devices fall under?
Among its 1 most recently registered device, the classes recorded for Scimedx Tekfile Services's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scimedx Tekfile Services in the registry?
The most recently registered devices listed for Scimedx Tekfile Services include SERODIA TP-PA.