Auspharm Intl., Ltd.
Country not established
- Devices
- 1
What Auspharm Intl., Ltd. makes
Auspharm Intl., Ltd. manufactures the Clotest, a rapid enzyme test for detecting *Campylobacter pylori* urease activity in stool samples. This diagnostic device provides a qualitative result to aid in identifying *Helicobacter pylori* infection.
The Clotest is classified as a Class I medical device under FDA regulations and is listed in the 510(k) database. The company is based in the United States.
Catalogue
Clotest, Campylobacter Pylori Urease Enzyme Test Ref K882199
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Auspharm Intl., Ltd. have in the registry?
The registry currently lists 1 device for Auspharm Intl., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Auspharm Intl., Ltd.'s devices?
Among its 1 most recently registered device, Auspharm Intl., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Auspharm Intl., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Auspharm Intl., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Auspharm Intl., Ltd. in the registry?
The most recently registered devices listed for Auspharm Intl., Ltd. include CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST.