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Myeloperoxidase IgG ELISA

DRG International Inc · Model EIA-2776 · UDI-DI 00840239027764

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The DRG Myeloperoxidase (MPO) IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibody to myeloperoxidase in human serum. The test 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-ANCA may be associated with autoimmune disorders such as Wegener’s granulomatosis, 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.