Consulting Wallah › Device Explorer › IVD & laboratory › Wash/cleaning solution IVD, automated/semi-automat
Device Explorer · FDA GUDID · GMDN 59058

Wash/cleaning solution IVD, automated/semi-automated system

A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

US‑registered devices256in commercial distribution
Companies39labelers on GUDID
Single‑use28%of device records
Sterile0%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Siemens Healthcare Diagnostics Inc.4216%
Diamond Diagnostics Inc.2811%
Randox Laboratories Limited156%
Beckman Coulter, Inc.145%
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag114%
Phoenix Diagnostics, Inc.104%
Vitalscientific94%
Horiba Abx Sas83%

Top labelers

CompanyDevicesShare
Siemens Healthcare Diagnostics Inc.4216%
Diamond Diagnostics Inc.2811%
Randox Laboratories Limited156%
Beckman Coulter, Inc.145%
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag114%
Phoenix Diagnostics, Inc.104%
Vitalscientific94%
Horiba Abx Sas83%
Carolina Liquid Chemistries Corporation83%
Beckman Coulter Ireland Inc.83%
Tokyo Boeki Medisys Inc.73%
Radiometer Medical Aps62%

Company = labeler of record on GUDID. 39 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BenchMark Special Stains Cleaning KitBenchMark Special Stains Wash IIDAKEWEPROBE CLEANSERDiatro•Hypoclean CCDiatro•CleanerRinse Solution II S4987 REF 944-155 600mLS8377 REF 944-136 *6 Cleaning solution Met II SoRinse Solution S4980 REF 944-130Cleaning Solution with additive S8375 REF 944-12S4970 Rinse 1 Solution for 600mL, for ABL7xxS5362 REF 943-906IDS-iSYS Wash Solution (Wash S)IDS-iSYS System Liquid (Syst. l)IDS ImmunocleanerBOND-PRIME

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

FDA product codes

CodeNameDevices
JCBDetergent43
PPMGeneral Purpose Reagent38
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US29
JGSELECTRODE, ION SPECIFIC, SODIUM18
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Us18
CEMELECTRODE, ION SPECIFIC, POTASSIUM17

GMDN & GCC registration

  • GMDN code 59058 · non‑implantable
  • Single‑use 28% · sterile 0% · Rx‑only 59% · 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) · 12Total Volume (Liter) · 2

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

No closely related category with 50+ devices.

How many wash/cleaning solution ivd, automated/semi-automated system products are registered in the US?

256 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wash/cleaning solution IVD, automated/semi-automated system", from 39 companies. The largest labeler is Siemens Healthcare Diagnostics Inc. with 16% of records.

Which FDA product codes apply?

JCB (Detergent), PPM (General Purpose Reagent), JJE (ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US), JGS (ELECTRODE, ION SPECIFIC, SODIUM)

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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