NIG

AIA-PACK CA 19-9

Advisory panel: Immunology
Total cleared: 11

Adverse events under product code NIG

product code NIG

Malfunction: 618
Total: 618

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NIG

K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack Ortho Clinical Diagnostics · 2023-08-09
K200997 — Lumipulse G CA19-9-N Fujirebio Diagnostics,Inc. · 2020-05-14
K191973 — Lumpipulse G CA19-9-N Fujirebio Dianostics, Inc. · 2019-10-22
K100375 — DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 Siemens Healthcare Diagnostics, Inc. · 2011-04-06
K052889 — VITROS CA 19-9 Fujirebio Diagnostics,Inc. · 2005-12-20
K052000 — ARCHITECT CA 19-9XR ASSAY Fujirebio Diagnostics,Inc. · 2005-10-25
K033038 — GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 Beckman Coulter, Inc. · 2003-12-29
K031393 — BAYER ADVIA CENTAUR CA 19-9 ASSAY Bayer Healthcare, LLC · 2003-06-24
K023239 — AIA-PACK CA 19-9 Tosoh Corp. · 2002-12-23
K023240 — ST AIA-PACK CA 19-9 Tosoh Corp. · 2002-12-23
K020566 — FUJIREBIO DIAGNOSTICS CA 19-9 RIA Fujirebio Diagnostics,Inc. · 2002-05-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.