Medtek Diagnostics, LLC
Country not established
- Devices
- 1
What Medtek Diagnostics, LLC makes
Medtek Diagnostics, LLC manufactures the INSTACCULT, a diagnostic device designed for rapid detection of *Clostridioides difficile* toxins in stool samples, supporting clinical decision-making in gastrointestinal infections.
The INSTACCULT is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) premarket notification process. The company is based in the United States.
Catalogue
Instaccult Ref K002930
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtek Diagnostics, LLC have in the registry?
The registry currently lists 1 device for Medtek Diagnostics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtek Diagnostics, LLC's devices?
Among its 1 most recently registered device, Medtek Diagnostics, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Medtek Diagnostics, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Medtek Diagnostics, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtek Diagnostics, LLC in the registry?
The most recently registered devices listed for Medtek Diagnostics, LLC include INSTACCULT.