Consulting Wallah › Device Explorer › IVD & laboratory › Multiple anti-neutrophil cytoplasmic antibody (ANC
Device Explorer · FDA GUDID · GMDN 55061

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using a fluorescent immunoassay method.

US‑registered devices94in commercial distribution
Companies8labelers on GUDID
Single‑use84%of device records
Sterile0%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Euroimmun Medizinische Labordiagnostika Ag4346%
Immuno Concepts Inc1819%
Immco Diagnostics, Inc.1213%
Inova Diagnostics, Inc.89%
Scimedx Corporation55%
Zeus Scientific, Inc.44%
Aesku.Diagnostics Gmbh & Co. Kg33%
Bio-Rad Laboratories, Inc.11%

Top labelers

CompanyDevicesShare
Euroimmun Medizinische Labordiagnostika Ag4346%
Immuno Concepts Inc1819%
Immco Diagnostics, Inc.1213%
Inova Diagnostics, Inc.89%
Scimedx Corporation55%
Zeus Scientific, Inc.44%
Aesku.Diagnostics Gmbh & Co. Kg33%
Bio-Rad Laboratories, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AESKUSLIDES ANCA EthanolAESKUSLIDES ANCA FormalinEUROPLUS Granulocyte Mosaic 32EUROPLUS Granulocyte Mosaic 32 EUROPatternIFA: Granulocyte Mosaic 2 EUROPatternIFA: Granulocyte Mosaic 13 EUROPatternEUROPLUS Granulocyte Mosaic 22 EUROPatternIFA: Granulocytes (EOH)IFA: Granulocyte Mosaic 13IFA: Granulocyte Mosaic 2EUROPLUS Granulocyte Mosaic 22IFA: Granulocytes (HCHO)KallestadIMMCO DIAGNOSTICSAnti-Neutrophil Cytoplasmic Antibodies (FormalinAnti-Neutrophil Cytoplasmic Antibodies (Ethanol-

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)111
PIVAutomated Indirect Immunofluorescence Microscope And Softwar34
MOBTEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)1

GMDN & GCC registration

  • GMDN code 55061 · non‑implantable
  • Single‑use 84% · sterile 0% · Rx‑only 26% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many multiple anti-neutrophil cytoplasmic antibody (anca) ivd, kit, fluorescent immunoassay products are registered in the US?

94 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay", from 8 companies. The largest labeler is Euroimmun Medizinische Labordiagnostika Ag with 46% of records.

Which FDA product codes apply?

MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), PIV (Automated Indirect Immunofluorescence Microscope And Softwar), MOB (TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA))

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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