Anti-PR3

ZEUS SCIENTIFIC, INC. · Model 2Z9691G · UDI-DI 00845533002745

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Anti Proteinase-3 (PR-3) is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninase-3 in human serum. This 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). ANCA may be associated with autoimmune disorders such as Wegener’s granulomatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.