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Device Explorer · FDA GUDID · GMDN 57871

Specimen processing instrument IVD

An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of

US‑registered devices125in commercial distribution
Companies17labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Thermo Fisher Scientific Oy3931%
Beckman Coulter, Inc.2218%
Aim Lab Automation Technologies Pty Ltd1512%
Siemens Healthcare Diagnostics Inc.97%
Becton, Dickinson And Company86%
Qiagen Gmbh65%
Roche Diagnostics Gmbh54%
Menarini Silicon Biosystems, Inc.43%

Top labelers

CompanyDevicesShare
Thermo Fisher Scientific Oy3931%
Beckman Coulter, Inc.2218%
Aim Lab Automation Technologies Pty Ltd1512%
Siemens Healthcare Diagnostics Inc.97%
Becton, Dickinson And Company86%
Qiagen Gmbh65%
Roche Diagnostics Gmbh54%
Menarini Silicon Biosystems, Inc.43%
Inpeco Sa43%
Roche Molecular Systems, Inc.32%
Abbott Laboratories32%
Wallac Oy22%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

cobas&#x00AE prime Pre-analytical Systemcobas&#x00AE prime Process Plus Modulecobas e 801 Immunoassay analyzerBCM for cobas 8100DxU 1800 System BridgeAliquoter & Labeler, TCACentrifuge Module, TCABuffer, TCACentrifuge Flex Module, TCABulk Interface ModuleStorageLoaderPerpendicular Bypass, TCA for Cold Storage Rack Parallel Bypass, TCA Tosoh G8TCA 800 Interface for cobas 8000Parallel Bypass, TCA Liaison XL

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

FDA product codes

CodeNameDevices
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted 59
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US9
JQWStation, Pipetting And Diluting, For Clinical Use8
JQPCalculator/data processing module, for clinical use7
JQWSTATION, PIPETTING AND DILUTING, FOR CLINICAL USE6
JJHClinical Sample Concentrator6

GMDN & GCC registration

  • GMDN code 57871 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 26% · 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 specimen processing instrument ivd products are registered in the US?

125 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Specimen processing instrument IVD", from 17 companies. The largest labeler is Thermo Fisher Scientific Oy with 31% of records.

Which FDA product codes apply?

LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted ), JJE (ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US), JQW (Station, Pipetting And Diluting, For Clinical Use), JQP (Calculator/data processing module, for clinical use)

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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