Consulting Wallah › Device Explorer › IVD & laboratory › Buffered sample diluent IVD
Device Explorer · FDA GUDID · GMDN 58237

Buffered sample diluent IVD

A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory speci

US‑registered devices295in commercial distribution
Companies55labelers on GUDID
Single‑use21%of device records
Sterile1%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Siemens Healthcare Diagnostics Inc.7425%
Sysmex Corporation3512%
Siemens Healthcare Diagnostics Products Ltd238%
Siemens Healthcare Diagnostics Products Gmbh93%
Beckman Coulter, Inc.93%
Shenzhen Yhlo Biotech Co., Ltd.83%
Diamond Diagnostics Inc.83%
Abbott Ireland Diagnostics83%

Top labelers

CompanyDevicesShare
Siemens Healthcare Diagnostics Inc.7425%
Sysmex Corporation3512%
Siemens Healthcare Diagnostics Products Ltd238%
Siemens Healthcare Diagnostics Products Gmbh93%
Beckman Coulter, Inc.93%
Shenzhen Yhlo Biotech Co., Ltd.83%
Diamond Diagnostics Inc.83%
Abbott Ireland Diagnostics83%
Wallac Oy62%
Euroimmun Medizinische Labordiagnostika Ag62%
Horiba Abx Sas62%
Ortho Clinical Diagnostics62%

Company = labeler of record on GUDID. 55 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

cobas pro Sample BufferMR Buffer SolutionMR Detergent SolutionSample DiluentBuffer MDELFIA Diluent 3DELFIA Diluent IIDiatro•Dil-5PDiatro•Dil-DIFFIDS-iSYS Diluent CPRECISION CHECK SOLUTION (PREC)ISE DILSERUM DILUENT (DIL SM)RANSOD DILUENT (RANSOD DIL)ISE DIL URNEXENT® Diluent 1

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

FDA product codes

CodeNameDevices
GIFDiluent, Blood Cell47
GIFDILUENT, BLOOD CELL45
PPMGeneral Purpose Reagent38
PPMGeneral purpose reagent12
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US10
CHPRADIOIMMUNOASSAY, ESTRADIOL6

GMDN & GCC registration

  • GMDN code 58237 · non‑implantable
  • Single‑use 21% · sterile 1% · 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 (Liter) · 33Total Volume (Milliliter) · 10Width (Inch) · 5

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

How many buffered sample diluent ivd products are registered in the US?

295 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Buffered sample diluent IVD", from 55 companies. The largest labeler is Siemens Healthcare Diagnostics Inc. with 25% of records.

Which FDA product codes apply?

GIF (Diluent, Blood Cell), GIF (DILUENT, BLOOD CELL), PPM (General Purpose Reagent), PPM (General purpose reagent)

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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