Consulting Wallah › Device Explorer › IVD & laboratory › Multiple blood gas/haemoximetry/electrolyte analyt
Device Explorer · FDA GUDID · GMDN 52858

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE)

US‑registered devices229in commercial distribution
Companies4labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Instrumentation Laboratory Company16472%
Radiometer Medical Aps5725%
Drew Scientific, Inc.42%
Beckman Coulter, Inc.42%

Top labelers

CompanyDevicesShare
Instrumentation Laboratory Company16472%
Radiometer Medical Aps5725%
Drew Scientific, Inc.42%
Beckman Coulter, Inc.42%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SC90ABL90 Sensor Cassette packSC90 50 BG, LYT, MET, OXI + QCABL80 SC80SP90ABL90 FLEX SP90ABL80 FLEX SP80ABL80 FLEX SP80 CO-OXJAS DiagnosticsGEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 75GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 15GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 30GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 45GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 60GEM Premier 7000 with iQM3 PAK (BG/COOX 75 TestsGEM Premier 7000 with iQM3 PAK (BG/COOX 150 Test

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

FDA product codes

CodeNameDevices
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH230
CEMELECTRODE, ION SPECIFIC, POTASSIUM86
CGAGLUCOSE OXIDASE, GLUCOSE86
GHSASSAY, CARBOXYHEMOGLOBIN86
GKRSYSTEM, HEMOGLOBIN, AUTOMATED86
JGSELECTRODE, ION SPECIFIC, SODIUM86

GMDN & GCC registration

  • GMDN code 52858 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 99% · 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 blood gas/haemoximetry/electrolyte analyte ivd, kit, multiple technologies products are registered in the US?

229 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, kit, multiple technologies", from 4 companies. The largest labeler is Instrumentation Laboratory Company with 72% of records.

Which FDA product codes apply?

CHL (ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH), CEM (ELECTRODE, ION SPECIFIC, POTASSIUM), CGA (GLUCOSE OXIDASE, GLUCOSE), GHS (ASSAY, CARBOXYHEMOGLOBIN)

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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