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ANCA Screen
ZEUS SCIENTIFIC, INC. · Model SM2Z9681G · UDI-DI 00845533002998
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510(k) clearances
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Description
The ANCA Screen is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody 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 and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use.
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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.