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Device Explorer · FDA GUDID · GMDN 56676

Multiple clinical chemistry analyser IVD, laboratory

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., micro

US‑registered devices199in commercial distribution
Companies31labelers on GUDID
Single‑use11%of device records
Sterile0%labelled sterile
Prescription55%Rx‑only share
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Share of device records

Diamond Diagnostics Inc.2613%
Abbott Laboratories2111%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.1910%
Siemens Healthcare Diagnostics Inc.158%
Beckman Coulter, Inc.158%
Horiba Abx Sas137%
Ortho-Clinical Diagnostics, Inc.126%
Biobase Biodustry(Shandong)Co., Ltd.105%

Top labelers

CompanyDevicesShare
Diamond Diagnostics Inc.2613%
Abbott Laboratories2111%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.1910%
Siemens Healthcare Diagnostics Inc.158%
Beckman Coulter, Inc.158%
Horiba Abx Sas137%
Ortho-Clinical Diagnostics, Inc.126%
Biobase Biodustry(Shandong)Co., Ltd.105%
Roche Diagnostics Gmbh95%
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag95%
Dynex Technologies, Inc.53%
Randox Laboratories Limited53%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

cobas pro SBL c 703cobas c 303 analytical unitcobas c 703 analytical unitSelf-Contained ISE Support BoxBIOBASEBIOBASEBK200miniCONTECWater Supply UnitDrainage UnitAccessory Kit of ISEManual rerun rack assemblySTAT sample rack assemblyCalibrator rack assemblyQC rack assemblyBS-480 Common Maintenance Kit(FDA)Lamp(12V,20W)

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

FDA product codes

CodeNameDevices
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Us77
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US57
JGSELECTRODE, ION SPECIFIC, SODIUM22
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use17
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted 7
CEMELECTRODE, ION SPECIFIC, POTASSIUM6

GMDN & GCC registration

  • GMDN code 56676 · non‑implantable
  • Single‑use 11% · sterile 0% · Rx‑only 55% · 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

Height (Millimeter) · 10Depth (Millimeter) · 10Width (Millimeter) · 10Width (Centimeter) · 4Depth (Centimeter) · 4Height (Centimeter) · 4

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

How many multiple clinical chemistry analyser ivd, laboratory products are registered in the US?

199 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple clinical chemistry analyser IVD, laboratory", from 31 companies. The largest labeler is Diamond Diagnostics Inc. with 13% of records.

Which FDA product codes apply?

JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Us), JJE (ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US), JGS (ELECTRODE, ION SPECIFIC, SODIUM), JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use)

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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