Consulting Wallah › Device Explorer › IVD & laboratory › Multiple electrolyte IVD, calibrator
Device Explorer · FDA GUDID · GMDN 52867

Multiple electrolyte IVD, calibrator

A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

US‑registered devices110in commercial distribution
Companies11labelers on GUDID
Single‑use24%of device records
Sterile0%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Diamond Diagnostics Inc.3532%
Phoenix Diagnostics, Inc.2825%
Medica Corporation1715%
Tokyo Boeki Medisys Inc.65%
Siemens Healthcare Diagnostics Inc.65%
Beckman Coulter, Inc.55%
Vitalscientific44%
Alfa Wassermann, Inc.44%

Top labelers

CompanyDevicesShare
Diamond Diagnostics Inc.3532%
Phoenix Diagnostics, Inc.2825%
Medica Corporation1715%
Tokyo Boeki Medisys Inc.65%
Siemens Healthcare Diagnostics Inc.65%
Beckman Coulter, Inc.55%
Vitalscientific44%
Alfa Wassermann, Inc.44%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.22%
Abbott Gmbh22%
Verichem Laboratories, Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Urine Standard (Indirect)(FDA)Serum Standard (Indirect)(FDA)Calibrator 2Calibrator SET A, BDialysis CalibratorUrine Calibrator SetCalibrator 1ISE CALIBRATORSENVOY 500 ISE CALIBRATOR KITACEAlfa WassermannPHOENIX DIAGNOSTICS, INC.Phoenix DiagnosticsPhoenix Diagnostics, Inc.Electrolyte Standard KitDimension Vista® V-LTYE® Standard B V-LYTE® Salt

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 Mixture32
JITCalibrator, Secondary32
JGSElectrode, Ion Specific, Sodium28
CEMElectrode, Ion Specific, Potassium20
CGZElectrode, Ion-Specific, Chloride14
JIHFlame Photometry, Lithium6

GMDN & GCC registration

  • GMDN code 52867 · non‑implantable
  • Single‑use 24% · sterile 0% · Rx‑only 47% · 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) · 15

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

How many multiple electrolyte ivd, calibrator products are registered in the US?

110 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple electrolyte IVD, calibrator", from 11 companies. The largest labeler is Diamond Diagnostics Inc. with 32% of records.

Which FDA product codes apply?

JIX (Calibrator, Multi-Analyte Mixture), JIT (Calibrator, Secondary), JGS (Electrode, Ion Specific, Sodium), CEM (Electrode, Ion Specific, Potassium)

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.

How do I get quotes?

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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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