Home › Aesku.Diagnostics GmbH & Co. KG › AESKULISA® PR3 sensitive
AESKULISA® PR3 sensitive
Aesku.Diagnostics GmbH & Co. KG · Model 30-7302US · UDI-DI 04250289503549
1
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities
Description
AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis. 30'+30'+30' automation incubation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-24 | Phadia Ab | Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA w |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.