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Device Explorer · FDA GUDID · GMDN 56747

Microorganism identification/antimicrobial-susceptibility analyser IVD

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphol

US‑registered devices52in commercial distribution
Companies6labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Beckman Coulter, Inc.2548%
Biomerieux , Inc.2140%
Trek Diagnostic Systems Limited24%
Becton, Dickinson And Company24%
Roche Molecular Systems, Inc.12%
Remel, Inc.12%

Top labelers

CompanyDevicesShare
Beckman Coulter, Inc.2548%
Biomerieux , Inc.2140%
Trek Diagnostic Systems Limited24%
Becton, Dickinson And Company24%
Roche Molecular Systems, Inc.12%
Remel, Inc.12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

cobas&#x00AE vivoDx SystemThermo Scientific™ Sensititre™ ARIS HiQ™ SystemSensititre™ OptiRead™VITEK® 2 KB UPDATE V2SVITEK®2VITEKVITEK® COMPACT PROVITEK® 2 Knowledge base update 09.03VITEK® 2 Software 09.02VITEK®2 CompactVITEK® 2 COMPACTVITEK® 2 XL BLUE MOD COLORMVITEK® 2 60 BLUE MOD COLORMSMART CARRIER STATIONVITEK® 2 Pipetter/Diluter Accessories KitSensititire® OptiRead™

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

FDA product codes

CodeNameDevices
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short34
LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT10
OUGMedical Device Data System9
LRGInstrument For Auto Reader & Interpretation Of Overnight Sus8
QIVCulture-based short-term incubation antimicrobial resistance1
JWYManual Antimicrobial Susceptibility Test Systems1

GMDN & GCC registration

  • GMDN code 56747 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 98% · 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

Depth (Inch) · 2Height (Inch) · 2Width (Inch) · 2

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

No closely related category with 50+ devices.

How many microorganism identification/antimicrobial-susceptibility analyser ivd products are registered in the US?

52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Microorganism identification/antimicrobial-susceptibility analyser IVD", from 6 companies. The largest labeler is Beckman Coulter, Inc. with 48% of records.

Which FDA product codes apply?

LON (System, Test, Automated, Antimicrobial Susceptibility, Short), LON (SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT), OUG (Medical Device Data System), LRG (Instrument For Auto Reader & Interpretation Of Overnight Sus)

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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