Wieslab AB
Country not established
- Devices
- 5
What Wieslab AB makes
Wieslab AB manufactures in vitro diagnostic test systems for detecting autoantibodies associated with autoimmune diseases. Their products include systems for screening and confirming anti-neutrophil cytoplasmic antibodies (ANCA), anti-glomerular basement membrane (anti-GBM) antibodies, and PR-3 specific ANCA markers. These tests are designed for laboratory use to aid in diagnosing conditions such as vasculitis and Goodpasture syndrome.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance process. Their products are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. regulatory requirements. Wieslab AB is based in the United States.
Catalogue
Wielisa Mpo Anca Test System Ref K974166
Regimes: 510(k) Registry: 510(k)Wielisa Anca Screening Kit Test System Ref K981748
Regimes: 510(k) Registry: 510(k)Wielisa Anti-Gbm Test System Ref K974169
Regimes: 510(k) Registry: 510(k)Wielisa Pr-3 Anca Test System Ref K974167
Regimes: 510(k) Registry: 510(k)Wielisa Anti-Gbm, Anca Screening Kit Test System Ref K981750
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wieslab AB have in the registry?
The registry currently lists 5 devices for Wieslab AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wieslab AB's devices?
Among its 5 most recently registered devices, Wieslab AB has devices listed in FDA 510(k) (5 devices).
What risk classes do Wieslab AB's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Wieslab AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wieslab AB in the registry?
The most recently registered devices listed for Wieslab AB include WIELISA MPO ANCA TEST SYSTEM, WIELISA ANCA SCREENING KIT TEST SYSTEM, WIELISA ANTI-GBM TEST SYSTEM and WIELISA PR-3 ANCA TEST SYSTEM.