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Asserachrom® IX:Ag

Model 00943 · DIAGNOSTICA STAGO · DI 03607450009439

GGP — Test, Qualitative And Quantitative Factor Deficiency · Class II · 21 CFR 864.7290

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.

11222019-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 2/device0506051012
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2022-0601
2025-0501
2025-1001
2025-1202
This device (reports/month)Average device in GGP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — DIAGNOSTICA STAGO

  • NAI 2025-09-09 Diagnostica Stago, Inc. · 0 citations
  • NAI 2025-09-09 Diagnostica Stago, Inc. · 0 citations
  • VAI 2024-09-04 Diagnostica Stago, Inc. · 1 citations
  • VAI 2024-09-04 Diagnostica Stago, Inc. · 1 citations
  • NAI 2018-04-12 Diagnostica Stago · 0 citations
  • NAI 2018-04-10 Diagnostica Stago · 0 citations
  • NAI 2018-04-10 Diagnostica Stago · 0 citations
  • VAI 2013-11-08 Diagnostica Stago, Inc. · 4 citations
  • VAI 2013-11-08 Diagnostica Stago, Inc. · 4 citations
  • VAI 2011-07-07 Diagnostica Stago · 2 citations
  • VAI 2011-07-07 Diagnostica Stago - Taverny Site · 1 citations
  • NAI 2011-07-05 Diagnostica Stago · 0 citations
  • NAI 2011-07-05 Diagnostica Stago · 0 citations