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AtheNA Multi-Lyte® ANA-II Plus Test System
ZEUS SCIENTIFIC, INC. · Model A21101 · UDI-DI 00845533000017
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 ZEUS AtheNA Multi-Lyte® ANA-II Plus Test System is intended for the semi-quantitative detection of IgG class antibody to eight separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum, and the qualitative detection of IgG class antibody to ANA. The test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. 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.