Consulting Wallah › Device Explorer › IVD & laboratory › Antibacterial susceptibility testing disc IVD
Device Explorer · FDA GUDID · GMDN 63834

Antibacterial susceptibility testing disc IVD

A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of

US‑registered devices146in commercial distribution
Companies5labelers on GUDID
Single‑use92%of device records
Sterile0%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Becton, Dickinson And Company11780%
Oxoid Limited139%
Hardy Diagnostics85%
Liofilchem Srl64%
Biomerieux , Inc.21%

Top labelers

CompanyDevicesShare
Becton, Dickinson And Company11780%
Oxoid Limited139%
Hardy Diagnostics85%
Liofilchem Srl64%
Biomerieux , Inc.21%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Thermo Scientific Oxoid Gepotidacin Disc (10 ug)Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 AntiOxoid Aztreonam/Avibactam Disc (30/20ug) AZA50Oxoid Lefamulin (20ug) LMU20 Antimicrobial SusceNAOxoid Eravacycline Disc (20ug) ERV20 AntimicrobiOxoid Meropenem/Vaborbactam Antimicrobial SuscepOxoid™ Moxifloxacin Antimicrobial SusceptibilityCeftazidime (10 ug) CAZ10 Antimicrobial SusceptiBLANK DISCSVITEK® REVEAL™ BC GN02-ASTVITEK® REVEAL™ SENSOR PANELHardyDisk™HardyDiskBD BBL™ Sensi-Disc™ Cefiderocol 30 µgBD BBL™ Sensi-Disc™ Ceftazidime/Avibactam 30/20

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

FDA product codes

CodeNameDevices
JTNSUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL146
JTNSusceptibility Test Discs, Antimicrobial36
JWYManual Antimicrobial Susceptibility Test Systems6
JTODiscs, Strips And Reagents, Microorganism Differentiation3
SANAutomated antimicrobial susceptibility test system for posit2
JTTSUSCEPTIBILITY TEST POWDERS, ANTIMICROBIAL2

GMDN & GCC registration

  • GMDN code 63834 · non‑implantable
  • Single‑use 92% · sterile 0% · Rx‑only 88% · 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 (Milliliter) · 1Outer Diameter (Millimeter) · 1

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

How many antibacterial susceptibility testing disc ivd products are registered in the US?

146 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Antibacterial susceptibility testing disc IVD", from 5 companies. The largest labeler is Becton, Dickinson And Company with 80% of records.

Which FDA product codes apply?

JTN (SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL), JTN (Susceptibility Test Discs, Antimicrobial), JWY (Manual Antimicrobial Susceptibility Test Systems), JTO (Discs, Strips And Reagents, Microorganism Differentiation)

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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