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AESKUSLIDES ANCA Ethanol

Model 54.050.US · Aesku.Diagnostics GmbH & Co. KG · DI 04250289510370

MOB — Test System, Antineutrophil Cytoplasmic Antibodies (Anca) · Class II · 21 CFR 866.5660

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

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

  • K172461 SESE 2018-03-23 (k number procode)

Manufacturer compliance record — Aesku.Diagnostics GmbH & Co. KG

  • VAI 2017-03-02 Aesku Group GmbH & Co. KG · 2 citations