FDA Device Intelligence
Home › Device types › MOB

Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

FDA product code MOB · Class 2 · Immunology

213
Registered devices
3
Adverse events
1
Recalls
75
510(k) clearances

Devices with this code

IFA: Granulocyte Mosaic 13 — EUROIMMUN Medizinische Labordiagnostika AGAESKULISA® MPO — Aesku.Diagnostics GmbH & Co. KGEUROPLUS Granulocyte Mosaic 22 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGKallestad ANCA — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IFA: Granulocytes (HCHO) — EUROIMMUN Medizinische Labordiagnostika AGKallestad ANCA — BIO-RAD LABORATORIES, INC.AESKULISA® PR3 sensitive — Aesku.Diagnostics GmbH & Co. KGKallestad ANCA — BIO-RAD LABORATORIES, INC.EUROPLUS Granulocyte Mosaic 22 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EUROPLUS Granulocyte Mosaic 22 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGIFA: Granulocyte Mosaic 2 EUROPattern — EUROIMMUN Medizinische Labordiagnostika AGAESKULISA® MPO — Aesku.Diagnostics GmbH & Co. KGpANCA (MPO) ELISA — DRG International IncIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IFA: Granulocytes (EOH) — EUROIMMUN Medizinische Labordiagnostika AGIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Trinity Biotech — CLARK LABORATORIES, INC.dIFine ANCA Classifier — VISIA LAB SRLEUROPLUS Granulocyte Mosaic 22 — EUROIMMUN Medizinische Labordiagnostika AGIFA: Granulocyte Mosaic 4 — EUROIMMUN Medizinische Labordiagnostika AGIFA: Granulocytes (HCHO) — EUROIMMUN Medizinische Labordiagnostika AG

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.