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Device Explorer · FDA GUDID · GMDN 52861

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detec

US‑registered devices56in commercial distribution
Companies9labelers on GUDID
Single‑use45%of device records
Sterile2%labelled sterile
Prescription25%Rx‑only share
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Share of device records

Siemens Healthcare Diagnostics Inc.1730%
Lifehealth814%
Abbott Point Of Care Inc.814%
Phoenix Diagnostics, Inc.712%
Infrared Laboratory Systems Llc611%
Diamond Diagnostics Inc.47%
Hunan Ehome Health Technology Co., Ltd.24%
Cleveland Diagnostics, Inc.24%

Top labelers

CompanyDevicesShare
Siemens Healthcare Diagnostics Inc.1730%
Lifehealth814%
Abbott Point Of Care Inc.814%
Phoenix Diagnostics, Inc.712%
Infrared Laboratory Systems Llc611%
Diamond Diagnostics Inc.47%
Hunan Ehome Health Technology Co., Ltd.24%
Cleveland Diagnostics, Inc.24%
Epocal Inc24%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sample Processing kits for Blood Analysis (CaninSample Processing kits for Blood Analysis (FelinSynermed®IsoPSA ControlsIsoPSA ReagentH3 CartridgeBG CartridgeCC CartridgeGL CartridgeH4 CartridgePHOENIX DIAGNOSTICS, INC.Phoenix DiagnosticsISE Internal Reference SolutionKCL Electrolyte SolutionISE CompensatorEPOC BGEM CREA TEST CARD

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

FDA product codes

CodeNameDevices
JGSElectrode, Ion Specific, Sodium14
CEMElectrode, Ion Specific, Potassium13
CGZElectrode, Ion-Specific, Chloride11
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph11
GKRSYSTEM, HEMOGLOBIN, AUTOMATED9
JGSELECTRODE, ION SPECIFIC, SODIUM8

GMDN & GCC registration

  • GMDN code 52861 · non‑implantable
  • Single‑use 45% · sterile 2% · Rx‑only 25% · 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

Total Volume (Milliliter) · 3

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

How many multiple blood gas/haemoximetry/electrolyte analyte ivd, reagent products are registered in the US?

56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent", from 9 companies. The largest labeler is Siemens Healthcare Diagnostics Inc. with 30% of records.

Which FDA product codes apply?

JGS (Electrode, Ion Specific, Sodium), CEM (Electrode, Ion Specific, Potassium), CGZ (Electrode, Ion-Specific, Chloride), CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)

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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