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Alegria Flash ENA Screen
ZEUS SCIENTIFIC, INC. · Model CL28051 · UDI-DI 00845533003063
Prescription
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510(k) clearances
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Adverse events
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Recalls
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Facilities
Description
The Alegria Flash ENA Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to Jo-1, SSA-52, SSA-60, SS-B, Scl-70, Sm, or sm-RNP in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD) Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), Systemic Sclerosis (SSC).
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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.