Consulting Wallah › Device Explorer › IVD & laboratory › Multiple blood gas/haemoximetry/electrolyte analyt
Device Explorer · FDA GUDID · GMDN 52860

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

A material which is used to verify the performance of 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 pressure of oxygen (

US‑registered devices223in commercial distribution
Companies12labelers on GUDID
Single‑use57%of device records
Sterile0%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Nova Biomedical Corporation6228%
Instrumentation Laboratory Company3516%
Radiometer Medical Aps2612%
Eurotrol B.V.219%
Bio-Rad Laboratories, Inc.178%
Rna Medical Division167%
Siemens Healthcare Diagnostics Inc.136%
Medica Corporation104%

Top labelers

CompanyDevicesShare
Nova Biomedical Corporation6228%
Instrumentation Laboratory Company3516%
Radiometer Medical Aps2612%
Eurotrol B.V.219%
Bio-Rad Laboratories, Inc.178%
Rna Medical Division167%
Siemens Healthcare Diagnostics Inc.136%
Medica Corporation104%
Abbott Point Of Care Inc.84%
Separation Technology, Inc.63%
Edan Instruments, Inc.52%
Radiometer America Inc.42%

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

Brand names on the register (sample)

Hematocrit ControlBlood Gas and Electrolyte ControlRANGE+ QUALICHECK LEV. 3 S7950RANGE+ QUALICHECK LEV. 2 S7940RANGE+ QUALICHECK LEV. 1 S7930HIGH METABOLITE QC, LEVEL 1AUTOCHECK 6+, LEVEL 4, S7865AUTOCHECK 6+, LEVEL 3, S7855AUTOCHECK 6+, LEVEL 2, S7845AUTOCHECK 6+, LEVEL 1, S7835AUTOCHECK 3+, LEVEL 4, S7365AUTOCHECK 3+, LEVEL 3, S7355AUTOCHECK 3+, LEVEL 2, S7345AUTOCHECK 3+, LEVEL 1, S7335S7765 AUTOCHECK TM 5+, LEVEL 4S7755 AUTOCHECK TM 5+, LEVEL 3

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

FDA product codes

CodeNameDevices
JJYMulti-analyte controls, all kinds (assayed)89
JJYMulti-Analyte Controls, All Kinds (Assayed)32
JJSControls for blood-gases, (assayed and unassayed)22
JJSCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)22
GLKControl, Hematocrit13
CHLElectrode measurement, blood-gases (pco2, po2) and blood ph9

GMDN & GCC registration

  • GMDN code 52860 · non‑implantable
  • Single‑use 57% · sterile 0% · Rx‑only 71% · 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, control products are registered in the US?

223 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, control", from 12 companies. The largest labeler is Nova Biomedical Corporation with 28% of records.

Which FDA product codes apply?

JJY (Multi-analyte controls, all kinds (assayed)), JJY (Multi-Analyte Controls, All Kinds (Assayed)), JJS (Controls for blood-gases, (assayed and unassayed)), JJS (CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED))

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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