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

Autoimmune EIA

Model 425-2120 · BIO-RAD LABORATORIES, INC. · DI 00847817018268

DHC — System, Test, Systemic Lupus Erythematosus · Class II · 21 CFR 866.5820

MID — System, Test, Anticardiolipin Immunological · Class II · 21 CFR 866.5660

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

UDILibrary device dossier · generated 2026-09-12 · 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 DHC, MID, MSV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BIO-RAD LABORATORIES, INC.

  • Warning Letter 2015-09-03 Bio-Rad Laboratories GmbH
  • NAI 2023-08-03 Bio-Rad Laboratories, Inc. · 0 citations
  • NAI 2023-08-03 Bio-Rad Laboratories, Inc. · 0 citations
  • VAI 2021-07-15 Bio-Rad Laboratories, Inc. · 0 citations
  • NAI 2019-06-04 Exact Diagnostics · 0 citations
  • NAI 2017-08-17 Bio-Rad Laboratories, Inc. · 0 citations
  • NAI 2017-08-17 Bio-Rad Laboratories, Inc. · 0 citations
  • NAI 2017-05-26 Bio-Rad Laboratories, Inc. · 0 citations
  • NAI 2017-05-26 Bio-Rad Laboratories, Inc. · 0 citations
  • NAI 2017-05-23 Bio-Rad Laboratories, Inc · 0 citations
  • NAI 2017-05-23 Bio-Rad Laboratories, Inc · 0 citations
  • NAI 2017-05-22 Bio-Rad Laboratories, Inc · 0 citations
  • NAI 2017-05-22 Bio-Rad Laboratories, Inc · 0 citations
  • NAI 2016-04-14 Bio-Rad Laboratories GmbH · 0 citations
  • OAI 2016-02-25 Bio-Rad Laboratories, Inc. · 1 citations
  • OAI 2016-02-25 Bio-Rad Laboratories, Inc. · 1 citations
  • OAI 2015-01-22 Bio-Rad Laboratories GmbH · 7 citations
  • NAI 2013-12-04 Bio-Rad Laboratories, Inc · 0 citations
  • NAI 2013-12-04 Bio-Rad Laboratories, Inc · 0 citations
  • NAI 2013-12-02 Bio-Rad Laboratories, Inc · 0 citations
  • NAI 2013-12-02 Bio-Rad Laboratories, Inc · 0 citations