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Device Explorer · FDA GUDID · GMDN 44407

High performance liquid chromatography analyser column IVD

A component of a high performance liquid chromatograph (HPLC) analyser that functions as a narrow flow-through tube through which different chemical constituents of a sample pass in a high pressure liquid stream at different rates, depending on their various c

US‑registered devices112in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Chromsystems Instruments + Chemicals Gmbh9888%
Waters Technologies Corporation76%
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.44%
Roche Diagnostics Gmbh33%

Top labelers

CompanyDevicesShare
Chromsystems Instruments + Chemicals Gmbh9888%
Waters Technologies Corporation76%
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.44%
Roche Diagnostics Gmbh33%

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

Brand names on the register (sample)

Rapid Cartridge C (iRapidC)Rapid Cartridge B (iRapidB)HPLC Cartridge (iHPLC)BioHermes Glycohemoglobin Analytical ColumnRestrictor CapillaryPrefilterPrecolumnPrecolumn CartridgeHPLC ColumnAnalytical ColumnTrap ColumnMaster ColumnMassTrakAcquityMassTrak™

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

FDA product codes

CodeNameDevices
KZRChromatography (Liquid, Gel), Clinical Use91
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted 7
DPMColumns, Liquid Chromatography7
DPMCOLUMNS, LIQUID CHROMATOGRAPHY3

GMDN & GCC registration

  • GMDN code 44407 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 3% · 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 high performance liquid chromatography analyser column ivd products are registered in the US?

112 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "High performance liquid chromatography analyser column IVD", from 4 companies. The largest labeler is Chromsystems Instruments + Chemicals Gmbh with 88% of records.

Which FDA product codes apply?

KZR (Chromatography (Liquid, Gel), Clinical Use), LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted ), DPM (Columns, Liquid Chromatography), DPM (COLUMNS, LIQUID CHROMATOGRAPHY)

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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