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Device Explorer · FDA GUDID · GMDN 52859

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressu

US‑registered devices86in commercial distribution
Companies8labelers on GUDID
Single‑use9%of device records
Sterile1%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Nova Biomedical Corporation6879%
Phoenix Diagnostics, Inc.56%
Horiba Abx Sas45%
Radiometer Medical Aps33%
Edan Instruments, Inc.22%
Horiba Instruments Incorporated22%
Siemens Healthcare Diagnostics Inc.11%
Rna Medical Division11%

Top labelers

CompanyDevicesShare
Nova Biomedical Corporation6879%
Phoenix Diagnostics, Inc.56%
Horiba Abx Sas45%
Radiometer Medical Aps33%
Edan Instruments, Inc.22%
Horiba Instruments Incorporated22%
Siemens Healthcare Diagnostics Inc.11%
Rna Medical Division11%

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

Brand names on the register (sample)

Calibrant Fluid PackCalibration Gas 2Calibration gas 1ABX PENTRA REFERENCE 280MLABX PENTRA REFERENCEABX PENTRA STANDARD 2ABX PENTRA STANDARD 1Phoenix DiagnosticsPointe Scientific, IncPointe ScientificRAPIDLab® 348/348EX HCT SlopeStat ProfileSTAT PROFILENOVARNA Medical

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

FDA product codes

CodeNameDevices
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE55
CHLElectrode measurement, blood-gases (pco2, po2) and blood ph16
JIXCalibrator, Multi-Analyte Mixture11
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH9
CGZELECTRODE, ION-SPECIFIC, CHLORIDE6
JGSELECTRODE, ION SPECIFIC, SODIUM6

GMDN & GCC registration

  • GMDN code 52859 · non‑implantable
  • Single‑use 9% · sterile 1% · Rx‑only 87% · 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) · 4

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

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

86 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, calibrator", from 8 companies. The largest labeler is Nova Biomedical Corporation with 79% of records.

Which FDA product codes apply?

JIX (CALIBRATOR, MULTI-ANALYTE MIXTURE), CHL (Electrode measurement, blood-gases (pco2, po2) and blood ph), JIX (Calibrator, Multi-Analyte Mixture), 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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