Consulting Wallah › Device Explorer › Software & digital › Clinical laboratory information system application
Device Explorer · FDA GUDID · GMDN 44082

Clinical laboratory information system application software

An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support

US‑registered devices847in commercial distribution
Companies14labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Scc Soft Computer79394%
Clinisys, Inc182%
Roche Diagnostics Gmbh61%
Technidata61%
Byg Informatique40%
Haemonetics Corporation40%
Becton, Dickinson And Company40%
Data Innovations Llc40%

Top labelers

CompanyDevicesShare
Scc Soft Computer79394%
Clinisys, Inc182%
Roche Diagnostics Gmbh61%
Technidata61%
Byg Informatique40%
Haemonetics Corporation40%
Becton, Dickinson And Company40%
Data Innovations Llc40%
Beckman Coulter, Inc.30%
Cirdan Imaging Limited10%
Medical Information Technology, Inc.10%
Sysmex America, Inc.10%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

navify® Lab Operationsnavify POC Operationsnavify Quality Controlcobas® infinity central labcobas infinity POCULTRA Laboratory Information Systemcobas&#x00AE infinity central labPOC ControllerLab ComposerYpocnYnaTDMindTDBactiLinkTD-WebTDWorkstationTDGenet

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

FDA product codes

CodeNameDevices
JQPCalculator/Data Processing Module, For Clinical Use836
NVVDigital Image, Storage And Communications, Non-Diagnostic, L16
JQPCalculator/data processing module, for clinical use12
MMHBlood Establishment Computer Software And Accessories6
MMHBlood Establishment Computer Software and Accessories4
OUGMedical Device Data System2

GMDN & GCC registration

  • GMDN code 44082 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 1% · 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 clinical laboratory information system application software products are registered in the US?

847 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Clinical laboratory information system application software", from 14 companies. The largest labeler is Scc Soft Computer with 94% of records.

Which FDA product codes apply?

JQP (Calculator/Data Processing Module, For Clinical Use), NVV (Digital Image, Storage And Communications, Non-Diagnostic, L), JQP (Calculator/data processing module, for clinical use), MMH (Blood Establishment Computer Software And Accessories)

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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