ANA Detect ELISA
Model EIA-4117 · DRG Instruments Gesellschaft mit beschränkter Haftung · DI 04048474041170
LJM — Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls · Class II · 21 CFR 866.5100
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)
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 Instruments Gesellschaft mit beschränkter Haftung
Nothing in the loaded window.