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EliA ß2-Glycoprotein I IgM Well

Model DECC055330 · Phadia AB · DI 07333066014760

MSV — System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) · Class II · 21 CFR 866.5660

UDILibrary device dossier · generated 2026-09-08 · 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.

01112023-03: 0 reports for this device; peer average 1/device03
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0301
This device (reports/month)Average device in MSV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K091845 — cites (transitively): K020752 (d1), K020758 (d1), K040449 (d1), K092983 (d1) — cited as predicate by K151799, K182747

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

Manufacturer compliance record — Phadia AB

  • NAI 2013-11-21 Phadia GmbH · 0 citations
  • NAI 2011-08-18 Phadia Ab · 0 citations
  • NAI 2011-08-18 Phadia Ab · 0 citations