Gradipore, Ltd.
AustraliaFDA applicant, unverified
- Devices
- 4
What Gradipore, Ltd. makes
Gradipore, Ltd. manufactures in vitro diagnostic reagents and devices for blood plasma analysis, including graded plasma lipid assays (high and low-density lipoprotein) and test kits for specific biochemical markers. Their portfolio also includes confirmatory reagents for laboratory testing, designed to measure components like cholesterol or triglycerides in clinical settings.
The company’s devices are regulated under FDA’s Class I and Class II categories, with several authorised via the 510(k) pathway. These products are intended for use in the United States, where they are listed with the FDA. The company is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Gradileiden V Test Ref K992456
Regimes: 510(k) Registry: 510(k)Lucor Confirmatory Reagent Ref K922156
Regimes: 510(k) Registry: 510(k)Lupo-Test Reagent Ref K903037
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gradipore, Ltd. have in the registry?
The registry currently lists 4 devices for Gradipore, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gradipore, Ltd.'s devices?
Among its 4 most recently registered devices, Gradipore, Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Gradipore, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gradipore, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gradipore, Ltd. in the registry?
The most recently registered devices listed for Gradipore, Ltd. include GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05, GRADILEIDEN V TEST, LUCOR CONFIRMATORY REAGENT and LUPO-TEST REAGENT.