Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

ANA-8-Profile ELISA

Model EIA-3563 · DRG International Inc · DI 00840239035639

LJM — Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls · Class II · 21 CFR 866.5100

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

  • None linked in the loaded window.

Manufacturer compliance record — DRG International Inc

  • VAI 2019-04-15 DRG International, Inc. · 6 citations
  • VAI 2014-11-26 DRG International, Inc. · 3 citations
  • VAI 2012-07-11 DRG International, Inc. · 2 citations