This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K981750 | WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM | 1998-07-22 |
| US | K981748 | WIELISA ANCA SCREENING KIT TEST SYSTEM | 1998-07-22 |
| US | K974166 | WIELISA MPO ANCA TEST SYSTEM | 1998-02-17 |
| CA | 13139 | WIELISA ANTI-GBM, ANCA SCREENING TEST KIT | Class II |
| CA | 14679 | WIELISA ANTI-PR3 ANTIBODIES KIT (ANTI-PROTEINASE 3) | Class II |
| CA | 14680 | WIELISA ANTI-MPO ANTIBODIES KIT (ANTI-MYELOPEROXIDASE) | Class II |