Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)
Model FA9601-1010 · ZEUS SCIENTIFIC, INC. · DI 00845533001960
MOB — Test System, Antineutrophil Cytoplasmic Antibodies (Anca) · Class II · 21 CFR 866.5660
PIV — Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use · Class II · 21 CFR 866.4750
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
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Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — ZEUS SCIENTIFIC, INC.
- NAI 2020-08-31 Zeus Scientific, Inc. · 0 citations
- NAI 2020-08-31 Zeus Scientific, Inc. · 0 citations
- VAI 2016-02-19 Zeus Scientific, Inc. · 2 citations
- VAI 2016-02-19 Zeus Scientific, Inc. · 2 citations
- NAI 2012-05-31 Zeus Scientific, Inc. · 0 citations
- NAI 2012-05-31 Zeus Scientific, Inc. · 0 citations