Diatech Diagnostica, Ltd.
Country not established
- Devices
- 3
What Diatech Diagnostica, Ltd. makes
Diatech Diagnostica, Ltd. manufactures rapid diagnostic tests for infectious disease detection, including urine-based screening devices and immunoassay tests for specific pathogens. Their portfolio includes point-of-care diagnostic tools for identifying microbial infections, such as those caused by bacteria or parasites, in clinical and home settings.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where regulatory compliance is managed through the FDA’s premarket notification process.
Catalogue
Uriscreen Ref K882211
Regimes: 510(k) Registry: 510(k)Diatech Igm-Mp Test Ref K895276
Regimes: 510(k) Registry: 510(k)Mp Test Ref K882596
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diatech Diagnostica, Ltd. have in the registry?
The registry currently lists 3 devices for Diatech Diagnostica, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diatech Diagnostica, Ltd.'s devices?
Among its 3 most recently registered devices, Diatech Diagnostica, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Diatech Diagnostica, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Diatech Diagnostica, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Diatech Diagnostica, Ltd. in the registry?
The most recently registered devices listed for Diatech Diagnostica, Ltd. include URISCREEN, DIATECH IGM-MP TEST and MP TEST.