ANCA Ethanol-Fixed (SCIMEDX)

Intended Use

The SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in human serum using ethanol-fixed human neutrophils as substrate. The test is intended as an aid in the diagnosis of Granulomatosis with Polyangiitis (GPA), idiopathic crescentic glomerulonephritis, microscopic polyarteritis, and pulmonary renal syndrome.

Registration / Clearance

FDA Cleared

CE Marked