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EUROLINE ENA Profile 9 Ag (IgG)

Model DL 1590-6401-9 G · EUROIMMUN Medizinische Labordiagnostika AG · DI 04049016124917

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

LKO — Anti-Rnp Antibody, Antigen And Control · Class II · 21 CFR 866.5100

LKP — Anti-Sm Antibody, Antigen And Control · Class II · 21 CFR 866.5100

LLL — Extractable Antinuclear Antibody, Antigen And Control · Class II · 21 CFR 866.5100

MQA — Anti-Ribosomal P Antibodies · 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

  • K140224 SESE 2014-12-09 (k number procode)

Predicate lineage

K140224 — cites (transitively): K113439 (d1), K000535 (d2), K021482 (d2), K040885 (d2), K050662 (d2), K052262 (d2)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — EUROIMMUN Medizinische Labordiagnostika AG

  • NAI 2015-06-11 EUROIMMUN Medizinische Labordiagnostika AG · 0 citations
  • NAI 2015-06-11 EUROIMMUN Medizinische Labordiagnostika AG · 0 citations