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c-ANCA (PR3) ELISA

DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-3596 · UDI-DI 04048474035964

MOB Prescription
10
510(k) clearances
3
Adverse events (1 deaths)
1
Recalls
25
Facilities

Description

c-ANCA (PR 3) ELISA is a test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma.

Recalls

DateFirmReason
2023-05-24Phadia AbComplaints 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

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Data 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.