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ANCA Screen IgG ELISA

DRG International Inc · Model EIA-2777 · UDI-DI 00840239027771

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The ANCA Screen ELISA test system is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA). MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS.

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

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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.