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Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

FDA product code MOB · Class 2 · Immunology

213
Registered devices
3
Adverse events
1
Recalls
74
510(k) clearances

Devices with this code

EUROPLUS Granulocyte Mosaic 22 — EUROIMMUN Medizinische Labordiagnostika AGpANCA (MPO) ELISA) — DRG Instruments Gesellschaft mit beschränkter HaftungIFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AGEUROPLUS Granulocyte Mosaic 22 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGIFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AGIFA: Granulocyte Mosaic 2 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IFA: Granulocyte Mosaic 13 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Myeloperoxidase IgG ELISA — DRG International IncEUROPLUS Granulocyte Mosaic 22 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Myeloperoxidase IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIFA: Granulocyte Mosaic 2 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGNOVA Lite® ANCA Kit — INOVA DIAGNOSTICS, INC.IFA: Granulocyte Mosaic 4 — EUROIMMUN Medizinische Labordiagnostika AGWIESLAB Capture PR3 ANCA — Svar Life Science ABIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EUROPLUS Granulocyte Mosaic 20 — EUROIMMUN Medizinische Labordiagnostika AGQUANTA Flash® MPO Reagents — INOVA DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.C-ANCA 120 Test(L) — SCIMEDX CORPORATION

Recent recalls

DateFirmReason
2023-05-24Phadia AbComplaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution rea

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.