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Device Explorer · FDA GUDID · GMDN 35476

Haematological cell analyser IVD

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light sc

US‑registered devices104in commercial distribution
Companies16labelers on GUDID
Single‑use23%of device records
Sterile1%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Horiba Abx Sas2625%
Sysmex Corporation1615%
Siemens Healthcare Diagnostics Inc.1514%
Abbott Laboratories99%
Beckman Coulter, Inc.66%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.55%
Advanced Instruments, Llc55%
Diamond Diagnostics Inc.55%

Top labelers

CompanyDevicesShare
Horiba Abx Sas2625%
Sysmex Corporation1615%
Siemens Healthcare Diagnostics Inc.1514%
Abbott Laboratories99%
Beckman Coulter, Inc.66%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.55%
Advanced Instruments, Llc55%
Diamond Diagnostics Inc.55%
Boule Medical Ab44%
Athelas, Inc.33%
Hemocue Ab22%
Pixcell Medical Technologies Ltd22%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Medonic M-seriesHemoCue® WBC AnalyzerHemoScreen0.5ml tube adpaterTube rack moduleAuto Hematology Analyzer BC-5390Auto Hematology Analyzer(FDA) BC-3600BC-3200 Hematology AnalyzerABACUS 3CP  Hematology AnalyzerAbacus 5 Hematology AnalyzerXQ-520 XQ-Series Automated Hematology AnalyzerXR-20 XR-Series Automated Hematology AnalyzerXR-10 XR-Series Automated HematologyAnalyzerXQ-320 XQ-Series Automated Hematology AnalyzerAutomated Hematology Analyzer XW-100Automated Hematology Analyzer XN-L series XN-550

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

FDA product codes

CodeNameDevices
GKZCounter, Differential Cell63
GKZCounter, differential cell55
GKLCounter, Cell, Automated (Particle Counter)7
GKLCOUNTER, CELL, AUTOMATED (PARTICLE COUNTER)2

GMDN & GCC registration

  • GMDN code 35476 · non‑implantable
  • Single‑use 23% · sterile 1% · Rx‑only 52% · 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

Depth (Millimeter) · 2Width (Millimeter) · 2Height (Millimeter) · 2

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

No closely related category with 50+ devices.

How many haematological cell analyser ivd products are registered in the US?

104 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Haematological cell analyser IVD", from 16 companies. The largest labeler is Horiba Abx Sas with 25% of records.

Which FDA product codes apply?

GKZ (Counter, Differential Cell), GKZ (Counter, differential cell), GKL (Counter, Cell, Automated (Particle Counter)), GKL (COUNTER, CELL, AUTOMATED (PARTICLE COUNTER))

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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