Graoipore, Ltd.
AustraliaFDA applicant, unverified
- Devices
- 1
What Graoipore, Ltd. makes
Graoipore, Ltd. manufactures the LUPO-TEST REAGENT, a diagnostic reagent used for specific laboratory testing purposes.
The LUPO-TEST REAGENT is classified as a Class I medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Lupo-Test Regeant Ref K922326
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Graoipore, Ltd. have in the registry?
The registry currently lists 1 device for Graoipore, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Graoipore, Ltd.'s devices?
Among its 1 most recently registered device, Graoipore, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Graoipore, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Graoipore, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Graoipore, Ltd. in the registry?
The most recently registered devices listed for Graoipore, Ltd. include LUPO-TEST REGEANT.